Profile
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- PROFILE EUDAMEDFDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- PROFILE Interference Screw EUDAMEDPROFILE CANNULATED INTERFERENCE SCREW ROUND HEAD 8 x 30mm FDA UDI
- Model / Reference
- PROFILE Interference Screw System EUDAMED230430 EUDAMEDFDA UDI
- Description
- PROFILE CANNULATED INTERFERENCE SCREW ROUND HEAD 8 x 30mm FDA UDI
Identifiers
- Catalog Number
- 230430 FDA UDI
- Primary DI / UDI-DI
- 10886705010486 EUDAMEDFDA UDI
- Basic UDI-DI
- 0886705a00052KA EUDAMED
- 510(k) Number
- K961234 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P09120605 INTERFERENCE SCREWS EUDAMED
- GMDN Term
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
Manufacturing Date
No
Category: Tendon/ligament bone anchor, non-bioabsorbable
Profile by Medos International Sarl — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0886705a00052KA | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED 6e52d72c-5162-4c68-8e10-e6ddad2aeffe 61 fields · synced Jul 9, 2026
- FDA UDI 76ac9724-7382-4f51-95bd-dc87b90d5400 36 fields · synced May 29, 2026