Identity
- Trade Name
- Osteon EUDAMED
- Device Name
- Osteon® PLA Interference Screws Ø 8mm x 30mm EUDAMED
- Model / Reference
- SCRW-OPIS830 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681781339057 EUDAMED
- Basic UDI-DI
- B-08681781339057 EUDAMED
- EMDN Code
- P09120605 INTERFERENCE SCREWS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Tendon/ligament bone anchor, non-bioabsorbable
The Osteon PLA Interference Screws Ø 8mm x 30mm are a type of medical device used in orthopedic surgery to treat bone fractures. These screws are designed to promote bone healing and integration, while minimizing the risk of implant failure.
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Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08681781339057 | Class III | Active |
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Manufacturer
- Manufacturer
- Bonegraft Biomaterials Co.
- EUDAMED SRN
- TR-MF-000015715
Sources (1)
- EUDAMED 995069a3-5300-41b3-9309-c11c106d8549 61 fields · synced Jul 10, 2026