Identity
- Trade Name
- FFX EUDAMEDFFX 11x2.5 FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- FFX implant EUDAMEDThe FFX implant is a sterile, single patient use, long-term implantable devices consisting of a D-shaped cage made of titanium with an oval shape that is designed to be filled with bone graft. The top and bottom surfaces of the cage have sawtooth-shaped surface to improve fixation to the bone. FDA UDI
- Model / Reference
- FFX EUDAMED57.000.10S EUDAMEDFDA UDI
- Description
- The FFX implant is a sterile, single patient use, long-term implantable devices consisting of a D-shaped cage made of titanium with an oval shape that is designed to be filled with bone graft. The top and bottom surfaces of the cage have sawtooth-shaped surface to improve fixation to the bone. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03770019503003 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03770019503003 EUDAMED
- 510(k) Number
- K232468 FDA UDI
- FDA Product Code
- MRW FDA UDI
- EMDN Code
- P09070101 SPINAL CAGES EUDAMED
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDU FDA UDI
- Market of Registration
- France 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
MR Conditional FDA UDI
Ffx by Sc Medica — Class IIb — 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-03770019503003 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Sc Medica
- EUDAMED SRN
- FR-MF-000002722
Sources (2)
- EUDAMED e4d375a5-47ae-4611-8a3b-1d80b2199733 61 fields · synced May 30, 2026
- FDA UDI b07e8eea-bc01-46f5-af44-60efe8533826 34 fields · synced May 29, 2026