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Inion OTPS™ Mini Plating System
EUDAMEDFDA UDIClass III (EU MDR)
Ref FRF-1215Ref FRF-1233Ref FRF-1005Ref FRF-1213Ref FRF-1036Ref FRF-1242Ref FRF-1204Ref FRF-1239Ref FRF-1214Ref FRF-1241Ref FRF-1212Ref FRF-1202Ref FRF-1208Ref FRF-1209Ref FRF-1216
by Inion Oy
Identity
- Trade Name
- Inion OTPS™ Mini Plating System EUDAMED2.5 mm Inion OTPS™ FDA UDI
- Generic Name
- Orthopaedic fixation plate, bioabsorbable FDA UDI
- Device Name
- Inion OTPS Screws EUDAMEDInion OTPS Mini Plates EUDAMED10 hole plate FDA UDI
- Model / Reference
- FRF-1215 EUDAMEDFRF-1233 EUDAMEDFRF-1005 EUDAMEDFRF-1213 EUDAMEDFRF-1036 EUDAMEDFRF-1242 EUDAMEDFRF-1204 EUDAMEDFRF-1239 EUDAMEDFRF-1214 EUDAMEDFRF-1241 EUDAMEDFRF-1212 EUDAMEDFRF-1202 EUDAMEDFRF-1208 EUDAMEDFRF-1209 EUDAMEDFRF-1216 EUDAMED1 FDA UDI
- Description
- 10 hole plate FDA UDI
Identifiers
- Catalog Number
- FRF-1036 FDA UDI
- Primary DI / UDI-DI
- 06438408010521 EUDAMED06438408010545 EUDAMED06438408005787 EUDAMED06438408010507 EUDAMED06438408005916 EUDAMEDFDA UDI06438408010583 EUDAMED06438408010453 EUDAMED06438408010552 EUDAMED06438408010514 EUDAMED06438408010576 EUDAMED06438408010491 EUDAMED06438408010439 EUDAMED06438408010477 EUDAMED06438408010484 EUDAMED06438408010538 EUDAMED
- Basic UDI-DI
- B-06438408010521 EUDAMEDB-06438408010545 EUDAMEDB-06438408005787 EUDAMEDB-06438408010507 EUDAMEDB-06438408005916 EUDAMEDB-06438408010583 EUDAMEDB-06438408010453 EUDAMEDB-06438408010552 EUDAMEDB-06438408010514 EUDAMEDB-06438408010576 EUDAMEDB-06438408010491 EUDAMEDB-06438408010439 EUDAMEDB-06438408010477 EUDAMEDB-06438408010484 EUDAMEDB-06438408010538 EUDAMED
- 510(k) Number
- K023887 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120606 OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS EUDAMEDP09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMED
- GMDN Term
- Orthopaedic fixation plate, bioabsorbable FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Inion OTPS™ Mini Plating System by Inion Oy — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06438408010521 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (16)
- EUDAMED 33daa3ba-3053-46c6-8a94-7b2385833ddf 61 fields · synced Aug 3, 2026
- EUDAMED b0fa467f-9011-4add-87cd-6c8d725c253f 61 fields · synced May 16, 2026
- EUDAMED 69000298-6ba7-4690-8e63-ffd2504a3aee 61 fields · synced May 16, 2026
- EUDAMED 6984c2dc-86b6-4e52-80d7-d378d72bf7ff 61 fields · synced May 16, 2026
- EUDAMED 7d906bf8-165a-4b3a-8922-37b15ca6ccda 61 fields · synced May 16, 2026
- EUDAMED 574fdf6f-4d79-4cce-bbf7-304fca45fd94 61 fields · synced May 17, 2026
- EUDAMED 89c5cc69-56f2-4cf2-b33b-e16f6c4a48e7 61 fields · synced May 17, 2026
- EUDAMED 44c65424-2a8d-4f5d-9f1e-b239b8d070ad 61 fields · synced May 17, 2026
- EUDAMED 52e9c517-8444-4cb4-a236-5fe445d14dc4 61 fields · synced May 18, 2026
- EUDAMED a867ab5b-5716-4e0f-81c7-1f6cb822f910 61 fields · synced May 18, 2026
- EUDAMED 274937d2-2d2e-4b30-b939-e8d174b76bc5 61 fields · synced May 18, 2026
- EUDAMED c06445c9-229a-48ac-8fc8-94e905f5855b 61 fields · synced May 18, 2026
- EUDAMED 7d40c62b-0868-4499-a4da-d7e6d456ed6e 61 fields · synced May 19, 2026
- EUDAMED a584f521-3639-4232-ac65-1880a4d67b53 61 fields · synced May 19, 2026
- EUDAMED 42912ed1-10f5-402c-a8ff-a51b33d0aa7b 61 fields · synced May 19, 2026
- FDA UDI b95e1bac-27f5-42d1-a5f1-b8b415284632 35 fields · synced May 30, 2026