Identity
- Trade Name
- fX EUDAMED
- Device Name
- fX® PLA Interference Screws Ø 10mm x 25mm EUDAMED
- Model / Reference
- SCRW-FXPIS1025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681781339866 EUDAMED
- Basic UDI-DI
- B-08681781339866 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
fX by Bonegraft Biomaterials Co. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
- Hi-Fi — Conmed Corporation · Class II
- FLIPTIGHT LOOP — RIVERPOINT MEDICAL LLC · Class II
- GII PANACRYL — DePuy Mitek, Inc. · Class II
- Power Button Adjustable Loop — RIVERPOINT MEDICAL LLC · Class II
- SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
- OrthoButton AL — RIVERPOINT MEDICAL LLC · Class II
- PROFILE — Medos International Sàrl · Class II
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-08681781339866 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bonegraft Biomaterials Co.
- EUDAMED SRN
- TR-MF-000015715
Sources (1)
- EUDAMED 493293ba-1427-4d03-9651-a552bb2339a4 61 fields · synced Jun 19, 2026