Identity
- Trade Name
- FFX EUDAMEDFFX 13x3.5 FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- 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
- Model / Reference
- FFX EUDAMED57.000.60S 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
- 03770019503058 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03770019503058 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
No
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-03770019503058 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sc Medica
- EUDAMED SRN
- FR-MF-000002722
Sources (2)
- EUDAMED d7ce9c9b-a509-4694-b75c-33f7a5ba0bad 61 fields · synced Jul 17, 2026
- FDA UDI 4fe76120-5493-438b-94c5-8bafec583f36 34 fields · synced May 29, 2026