Loqteq®
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- LOQTEQ® EUDAMEDFDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- LOQTEQ® VA Distal Fibula Plate 2.7/3.5, 4 holes, L 87, L Titanium FDA UDI
- Model / Reference
- PA 3564-04-2 EUDAMEDFDA UDIBone plates (non-sterile) EUDAMED
- Description
- LOQTEQ® VA Distal Fibula Plate 2.7/3.5, 4 holes, L 87, L Titanium FDA UDI
Identifiers
- Catalog Number
- PA 3564-04-2 FDA UDI
- Primary DI / UDI-DI
- 04042409355134 EUDAMEDFDA UDI
- Basic UDI-DI
- 40424090143H4 EUDAMED
- 510(k) Number
- K161747 FDA UDI
- FDA Product Code
- HRS 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 UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Germany EUDAMED
- 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
Category: Orthopaedic fixation plate, non-bioabsorbable
Loqteq® by aap Implantate AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
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Cleared under the same submission
K161747 also covers:
- LOQTEQ® — aap Implantate AG
- LOQTEQ® — aap Implantate AG
- LOQTEQ® — aap Implantate AG
- LOQTEQ® — aap Implantate AG
- LOQTEQ® — aap Implantate AG
- LOQTEQ® — aap Implantate AG
- LOQTEQ® — aap Implantate AG
- LOQTEQ® — aap Implantate AG
- LOQTEQ® — aap Implantate AG
- LOQTEQ® — aap Implantate AG
- LOQTEQ® — aap Implantate AG
- LOQTEQ® — aap Implantate AG
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- aap Implantate AG
Sources (2)
- FDA UDI 8deda238-583c-4a1d-9541-6ea852580a39 35 fields · synced Oct 5, 2026
- EUDAMED b06c2901-099c-4db8-96fb-c0d49833c1f3 61 fields · synced Oct 5, 2026