aap LOQTEQ Distal Lateral Humerus Plate 2.7/3.5
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- LOQTEQ® EUDAMEDFDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- LOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 6h, L 105, L Titanium FDA UDILOQTEQ® VA Distal Fibula Plate 2.7/3.5, 6 holes, L 111, L Titanium FDA UDILOQTEQ® VA Dist. Medial Tibia Plate 3.5, 10 holes, L 194, L Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 8h, L 131, R Titanium FDA UDILOQTEQ® VA Distal Medial Humerus Plate, 2 holes, L 85, L, Titanium FDA UDILOQTEQ® VA Dist. Medial Tibia Plate 3.5, 6 holes, L 142, R Titanium FDA UDILOQTEQ® VA Distal Medial Humerus Plate, 11 holes, L 202, R, Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 12h, L 183, R Titanium FDA UDILOQTEQ® VA Olecranon Plate, 8 holes, L 164, R, Titanium FDA UDILOQTEQ® VA Distal Medial Humerus Plate, 7 holes, L 150, L, Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 16h, L 231, R Titanium FDA UDILOQTEQ® VA Dist. Medial Tibia Plate 3.5, 10 holes, L 194, R Titanium FDA UDILOQTEQ® VA Distal Medial Humerus Plate, 7 holes, L 150, R, Titanium FDA UDILOQTEQ® VA Distal Fibula Plate 2.7/3.5, 8 holes, L 135, L Titanium FDA UDILOQTEQ® VA Distal Lateral Humerus Plate, 5 holes, L 125, R, Titanium FDA UDILOQTEQ® VA Olecranon Plate, 6 holes, L 138, R, Titanium FDA UDILOQTEQ® VA Olecranon Plate, 8 holes, L 164, L, Titanium FDA UDILOQTEQ® VA Olecranon Plate, 4 holes, L 112, R, Titanium FDA UDILOQTEQ® VA Distal Lateral Humerus Plate, 5 holes, L 125, L, Titanium FDA UDILOQTEQ® VA Distal Dorsolateral Humerus Plate, 7 holes, L 154, R, Titanium FDA UDILOQTEQ® VA Distal Dorsolateral Humerus Plate, 2 holes, L 89, R, Titanium FDA UDILOQTEQ® VA Distal Dorsolateral Humerus Plate, 2 holes, L 89, L, Titanium FDA UDILOQTEQ® VA Olecranon Plate, 2 holes, L 86, R, Titanium FDA UDILOQTEQ® VA Dist. Medial Tibia Plate 3.5, 4 holes, L 116, R Titanium FDA UDILOQTEQ® VA Olecranon Plate, 10 holes, L 190, R, Titanium FDA UDILOQTEQ® VA Dist. Medial Tibia Plate 3.5, 3 holes, L 103, R Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 12h, L 183, L Titanium FDA UDILOQTEQ® VA Distal Medial Humerus Plate, 5 holes, L 124, L, Titanium FDA UDILOQTEQ® VA Distal Lateral Humerus Plate, 3 holes, L 99, R, Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 10h, L 157, L Titanium FDA UDILOQTEQ® VA Dist. Medial Tibia Plate 3.5, 6 holes, L 142, L Titanium FDA UDILOQTEQ® VA Distal Fibula Plate 2.7/3.5, 3 holes, L 75, R Titanium FDA UDILOQTEQ® VA Distal Fibula Plate 2.7/3.5, 8 holes, L 135, R Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 14h, L 209, R Titanium FDA UDILOQTEQ® VA Distal Lateral Humerus Plate, 3 holes, L 99, L, Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 8h, L 131, L Titanium FDA UDILOQTEQ® VA Distal Lateral Humerus Plate, 7 holes, L 151, R, Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 14h, L 209, L Titanium FDA UDI
- Model / Reference
- PA 3564-06-2 EUDAMEDFDA UDIPH 3524-02-2 EUDAMEDFDA UDIPU 3533-08-2 EUDAMEDFDA UDIPH 3543-05-2 EUDAMEDFDA UDIPU 3533-06-2 EUDAMEDFDA UDIPU 3533-04-2 EUDAMEDFDA UDIPH 3534-02-2 EUDAMEDFDA UDIPU 3533-02-2 EUDAMEDFDA UDIPH 3543-03-2 EUDAMEDFDA UDIPA 3563-03-2 EUDAMEDFDA UDIPH 3544-03-2 EUDAMEDFDA UDIPH 3543-07-2 EUDAMEDFDA UDIBone plates (non-sterile) EUDAMEDPA 3524-06-2 FDA UDIPA 3534-10-2 FDA UDIPA 3523-08-2 FDA UDIPA 3533-06-2 FDA UDIPH 3523-11-2 FDA UDIPA 3523-12-2 FDA UDIPH 3524-07-2 FDA UDIPA 3523-16-2 FDA UDIPA 3533-10-2 FDA UDIPH 3523-07-2 FDA UDIPA 3564-08-2 FDA UDIPU 3534-08-2 FDA UDIPH 3544-05-2 FDA UDIPH 3533-07-2 FDA UDIPH 3533-02-2 FDA UDIPA 3533-04-2 FDA UDIPU 3533-10-2 FDA UDIPA 3533-03-2 FDA UDIPA 3524-12-2 FDA UDIPH 3524-05-2 FDA UDIPA 3524-10-2 FDA UDIPA 3534-06-2 FDA UDIPA 3563-08-2 FDA UDIPA 3523-14-2 FDA UDIPA 3524-08-2 FDA UDIPA 3524-14-2 FDA UDI
- Description
- LOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 6h, L 105, L Titanium FDA UDILOQTEQ® VA Distal Fibula Plate 2.7/3.5, 6 holes, L 111, L Titanium FDA UDILOQTEQ® VA Dist. Medial Tibia Plate 3.5, 10 holes, L 194, L Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 8h, L 131, R Titanium FDA UDILOQTEQ® VA Distal Medial Humerus Plate, 2 holes, L 85, L, Titanium FDA UDILOQTEQ® VA Dist. Medial Tibia Plate 3.5, 6 holes, L 142, R Titanium FDA UDILOQTEQ® VA Distal Medial Humerus Plate, 11 holes, L 202, R, Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 12h, L 183, R Titanium FDA UDILOQTEQ® VA Olecranon Plate, 8 holes, L 164, R, Titanium FDA UDILOQTEQ® VA Distal Medial Humerus Plate, 7 holes, L 150, L, Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 16h, L 231, R Titanium FDA UDILOQTEQ® VA Dist. Medial Tibia Plate 3.5, 10 holes, L 194, R Titanium FDA UDILOQTEQ® VA Distal Medial Humerus Plate, 7 holes, L 150, R, Titanium FDA UDILOQTEQ® VA Distal Fibula Plate 2.7/3.5, 8 holes, L 135, L Titanium FDA UDILOQTEQ® VA Distal Lateral Humerus Plate, 5 holes, L 125, R, Titanium FDA UDILOQTEQ® VA Olecranon Plate, 6 holes, L 138, R, Titanium FDA UDILOQTEQ® VA Olecranon Plate, 8 holes, L 164, L, Titanium FDA UDILOQTEQ® VA Olecranon Plate, 4 holes, L 112, R, Titanium FDA UDILOQTEQ® VA Distal Lateral Humerus Plate, 5 holes, L 125, L, Titanium FDA UDILOQTEQ® VA Distal Dorsolateral Humerus Plate, 7 holes, L 154, R, Titanium FDA UDILOQTEQ® VA Distal Dorsolateral Humerus Plate, 2 holes, L 89, R, Titanium FDA UDILOQTEQ® VA Distal Dorsolateral Humerus Plate, 2 holes, L 89, L, Titanium FDA UDILOQTEQ® VA Olecranon Plate, 2 holes, L 86, R, Titanium FDA UDILOQTEQ® VA Dist. Medial Tibia Plate 3.5, 4 holes, L 116, R Titanium FDA UDILOQTEQ® VA Olecranon Plate, 10 holes, L 190, R, Titanium FDA UDILOQTEQ® VA Dist. Medial Tibia Plate 3.5, 3 holes, L 103, R Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 12h, L 183, L Titanium FDA UDILOQTEQ® VA Distal Medial Humerus Plate, 5 holes, L 124, L, Titanium FDA UDILOQTEQ® VA Distal Lateral Humerus Plate, 3 holes, L 99, R, Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 10h, L 157, L Titanium FDA UDILOQTEQ® VA Dist. Medial Tibia Plate 3.5, 6 holes, L 142, L Titanium FDA UDILOQTEQ® VA Distal Fibula Plate 2.7/3.5, 3 holes, L 75, R Titanium FDA UDILOQTEQ® VA Distal Fibula Plate 2.7/3.5, 8 holes, L 135, R Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 14h, L 209, R Titanium FDA UDILOQTEQ® VA Distal Lateral Humerus Plate, 3 holes, L 99, L, Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 8h, L 131, L Titanium FDA UDILOQTEQ® VA Distal Lateral Humerus Plate, 7 holes, L 151, R, Titanium FDA UDILOQTEQ® VA Dist. Anterolat. Tibia Plate 3.5, 14h, L 209, L Titanium FDA UDI
Identifiers
- Catalog Number
- PA 3524-06-2 FDA UDIPA 3564-06-2 FDA UDIPA 3534-10-2 FDA UDIPA 3523-08-2 FDA UDIPA 3533-06-2 FDA UDIPA 3523-12-2 FDA UDIPA 3523-16-2 FDA UDIPA 3533-10-2 FDA UDIPA 3564-08-2 FDA UDIPA 3533-04-2 FDA UDIPA 3533-03-2 FDA UDIPA 3524-12-2 FDA UDIPA 3524-10-2 FDA UDIPA 3534-06-2 FDA UDIPA 3563-03-2 FDA UDIPA 3563-08-2 FDA UDIPA 3523-14-2 FDA UDIPA 3524-08-2 FDA UDIPA 3524-14-2 FDA UDI
- Primary DI / UDI-DI
- 04042409355141 EUDAMEDFDA UDI04042409388477 EUDAMEDFDA UDI04042409389061 EUDAMEDFDA UDI04042409388859 EUDAMEDFDA UDI04042409389054 EUDAMEDFDA UDI04042409389047 EUDAMEDFDA UDI04042409388682 EUDAMEDFDA UDI04042409389030 EUDAMEDFDA UDI04042409388842 EUDAMEDFDA UDI04042409355073 EUDAMEDFDA UDI04042409388897 EUDAMEDFDA UDI04042409388866 EUDAMEDFDA UDI04042409385742 FDA UDI04042409386053 FDA UDI04042409385681 FDA UDI04042409385964 FDA UDI04042409388453 FDA UDI04042409385704 FDA UDI04042409388507 FDA UDI04042409385728 FDA UDI04042409385988 FDA UDI04042409388446 FDA UDI04042409355158 FDA UDI04042409389122 FDA UDI04042409388903 FDA UDI04042409388668 FDA UDI04042409388637 FDA UDI04042409385957 FDA UDI04042409389078 FDA UDI04042409385940 FDA UDI04042409385773 FDA UDI04042409388491 FDA UDI04042409385766 FDA UDI04042409386039 FDA UDI04042409355103 FDA UDI04042409385711 FDA UDI04042409385759 FDA UDI04042409385780 FDA UDI
- Basic UDI-DI
- 40424090142H2 EUDAMED40424090144H6 EUDAMED40424090161H6 EUDAMED40424090145H8 EUDAMED40424090143H4 EUDAMED
- FDA Product Code
- HRS FDA 510(k)FDA UDI
- EMDN Code
- P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
The aap LOQTEQ Distal Lateral Humerus Plate 2.7/3.5 is an orthopedic fixation device classified as a Distal Humerus Plate (HRS product code). It is designed for internal fixation of distal humerus fractures, osteotomies, or non-unions, providing stable anatomical alignment and compression to aid bone healing.
This device is supplied sterile and intended for single-use. It is approved under the FDA 510K pathway (K161696) and meets MDR requirements. The plate is manufactured by aap Implantate AG, based in Berlin, Germany, and is distributed with associated surgical instruments for precise placement. Compatibility with MRI is not specified in the available data.
Frequently asked questions
What types of bone conditions is the aap LOQTEQ Distal Lateral Humerus Plate 2.7/3.5 specifically designed to treat?
This plate is designed for internal fixation of distal humerus fractures, osteotomies (surgical cuts to realign bone), or non-unions (failed bone healing). It provides stable anatomical alignment and compression to support proper bone healing in these cases.
Is the aap LOQTEQ Distal Lateral Humerus Plate 2.7/3.5 meant for reuse in multiple patients, or is it single-use only?
The device is explicitly intended for single-use only, as stated in the manufacturer’s specifications. It is supplied sterile to ensure safety and efficacy for one surgical procedure.
What regulatory pathways has the aap LOQTEQ Distal Lateral Humerus Plate 2.7/3.5 followed for approval, and what does that mean for its use?
The plate was cleared via the FDA’s 510(k) pathway (K161696) under the Traditional review process, with a determination of Substantial Equivalence to a predicate device. It also meets the requirements of the EU’s Medical Device Regulation (MDR). This means it has undergone evaluation to demonstrate safety and performance for its intended orthopedic use.
Does the aap LOQTEQ Distal Lateral Humerus Plate 2.7/3.5 come with specialized tools for placement, and if so, what are they for?
Yes, the device is distributed with associated surgical instruments. These tools are designed to assist in precise placement of the plate during surgery, ensuring accurate alignment and fixation of the distal humerus.
How should the aap LOQTEQ Distal Lateral Humerus Plate 2.7/3.5 be stored before use, given it is sterile?
Since the plate is supplied sterile, it should be stored in its original packaging until ready for use. The packaging is likely designed to maintain sterility, so it should remain unopened and protected from contamination until the surgical procedure begins.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: aap Implantate AG | LOQTEQ® Plating System, Humerus compression plate - LOQTEQ® 2.7 - aap Implantate - distal ..., aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5, AAP LOQTEQ Distal Dorsolateral Humerus Plate 2.7/3.5 Manual
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K161696 | Class II | Active |
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Manufacturer
- Manufacturer
- aap Implantate AG
Sources (51)
- FDA 510(k) K161696 24 fields · synced Oct 6, 2026
- FDA UDI b6069dd9-ae54-47c0-bc86-69476bd73efe 35 fields · synced May 27, 2026
- FDA UDI ddeff49d-5823-4294-97bc-e203646759db 35 fields · synced May 29, 2026
- FDA UDI e460c5f8-0c47-4e02-acf6-ccdf2e7ff3c7 35 fields · synced May 29, 2026
- FDA UDI c8c3de58-5596-4405-96a1-f4a3f0fab6ee 35 fields · synced May 29, 2026
- FDA UDI 38585954-f3a8-46a4-8a75-bca4e52acab5 34 fields · synced May 29, 2026
- FDA UDI 17271c0d-0480-408f-801e-b697abcfdd5e 35 fields · synced May 30, 2026
- FDA UDI 9576daa1-a8d2-4bb9-8cbe-0d741f138c47 34 fields · synced May 30, 2026
- FDA UDI 1e512fb7-a8fb-414b-8f2e-e42845252ae1 35 fields · synced May 30, 2026
- FDA UDI 0f626b45-3a6c-420a-911c-5d8d753e0f5f 34 fields · synced May 30, 2026
- FDA UDI 0b5ed605-cb04-4419-9836-a6074fa28fb7 34 fields · synced May 30, 2026
- FDA UDI ef213cdb-ded1-426f-90c0-b4e997b96196 35 fields · synced May 30, 2026
- FDA UDI 9d768f0f-0e1d-4281-b46d-bf23c7abdba3 35 fields · synced May 30, 2026
- FDA UDI dd9e58c3-6c46-4603-a1b0-ac83d5732878 34 fields · synced May 30, 2026
- FDA UDI b41e033a-babe-46a4-8cba-42fde94ed5a3 35 fields · synced May 30, 2026
- FDA UDI d7e40e57-254a-4faa-853f-e7e804005471 34 fields · synced May 30, 2026
- FDA UDI 7b0a0929-77ab-49b2-b67a-5bbe772c512b 34 fields · synced May 30, 2026
- FDA UDI 66eff9d4-3917-46c0-b896-f0e390cce3de 34 fields · synced May 30, 2026
- FDA UDI 1e734d69-f23f-4d85-8ce7-b6ce141eb303 34 fields · synced May 30, 2026
- FDA UDI 7baaebb9-c848-41c1-b2a6-8bd72387fdeb 34 fields · synced May 30, 2026
- FDA UDI 1b7f7b83-90b3-4450-96de-ca3b0c8cdfe5 34 fields · synced May 30, 2026
- FDA UDI dfd44dda-d36b-4e16-93f3-33d2fe296635 34 fields · synced May 30, 2026
- FDA UDI 1aacfe2e-7533-45c7-8ea2-46dcde92d600 34 fields · synced May 30, 2026
- FDA UDI 5179a42c-4c82-4e00-bd6d-cdad5d9af386 34 fields · synced May 30, 2026
- FDA UDI c2d35489-57a4-4121-9e73-84ad87dd7f7c 35 fields · synced May 30, 2026
- FDA UDI 1fee99fc-c5b9-4911-8cb0-4cd373d09437 34 fields · synced May 30, 2026
- FDA UDI 0d78e13a-d364-45ae-a346-e9f95282db78 35 fields · synced May 30, 2026
- FDA UDI 24cc8615-ff4f-470c-83a5-cdfc9ff7bb59 35 fields · synced May 30, 2026
- FDA UDI 8a2df746-86c8-455a-beb5-75eb5c38ed66 34 fields · synced May 30, 2026
- FDA UDI 6e4b8259-5f6a-4d73-a4af-4ff44a787a15 34 fields · synced May 30, 2026
- FDA UDI 20afad3d-d7c9-4d55-94c5-cee66ef2cdd3 35 fields · synced May 30, 2026
- FDA UDI 33589fcf-a80f-446d-88a2-3a515166625d 35 fields · synced May 30, 2026
- FDA UDI 012f93e4-90d9-471c-996d-57a3cdbd8383 35 fields · synced May 30, 2026
- FDA UDI 3cc9e2a0-0b0b-44d8-a9ad-ea023ddffce3 35 fields · synced May 30, 2026
- FDA UDI 655a44b6-768b-439e-9550-f4830961dce9 35 fields · synced May 30, 2026
- FDA UDI 368dcd39-5b96-480b-8dc5-e41001f07b64 34 fields · synced May 30, 2026
- FDA UDI 1fa25d60-951f-4109-9dcc-ca64ffa3ab80 35 fields · synced May 30, 2026
- FDA UDI bc1794a3-301c-418a-ba0a-3abb853c8a23 34 fields · synced May 30, 2026
- FDA UDI 15f05910-b229-4b8c-a44c-1638b8ccce87 35 fields · synced May 30, 2026
- EUDAMED 94bea0db-7b53-4e1e-a56b-9f7240010015 61 fields · synced Jun 20, 2026
- EUDAMED 42a69d62-a4bc-4d19-b71d-6e1d0ba6f241 61 fields · synced Jul 8, 2026
- EUDAMED 9ada548d-b8de-4e25-81a3-ccb896c6ad51 61 fields · synced Jul 8, 2026
- EUDAMED 233b1ef5-eea1-4a8f-a1ce-e63ee0084584 61 fields · synced Jul 9, 2026
- EUDAMED 40a4bc73-196b-4baf-8882-187b927f0a7f 61 fields · synced Jul 9, 2026
- EUDAMED bb185c3d-7e1b-4d8a-b460-85d48351d8c4 61 fields · synced Jul 9, 2026
- EUDAMED cabf6264-96c5-4834-a487-dfea45d46337 61 fields · synced Jul 9, 2026
- EUDAMED 47858cd0-c0ad-41ab-aa7f-09b77caf3197 61 fields · synced Jul 9, 2026
- EUDAMED e516591c-9095-4807-8848-6515a4a238b5 61 fields · synced Jul 10, 2026
- EUDAMED c03c009b-afd6-427d-b8ec-ef2295d6e9a9 61 fields · synced Jul 10, 2026
- EUDAMED 7b974476-5f0d-4187-92d1-7d29b23e37a5 61 fields · synced Jul 10, 2026
- EUDAMED 763755a2-d5be-4dcf-a731-f13105bfb68f 61 fields · synced Jul 11, 2026