Identity
- Trade Name
- GoLIF! Cage 22 x 14mm EUDAMEDGoLIF! Lumbar Interbody Fusion System FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- GoLIF! Cage 22 x 14mm EUDAMEDGoLIF! Lumbar Interbody Fusion Device, 1 PEEK polymers cage 22mm x 14mm FDA UDI
- Model / Reference
- 3102214 EUDAMEDFDA UDI
- Description
- GoLIF! Lumbar Interbody Fusion Device, 1 PEEK polymers cage 22mm x 14mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640387660331 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640387660331 EUDAMED
- 510(k) Number
- K250186 FDA UDI
- FDA Product Code
- MAX FDA UDI
- EMDN Code
- P09070101 SPINAL CAGES EUDAMED
- GMDN Term
- Polymeric spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Market of Registration
- Denmark 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
GoLIF! Cage 22 x 14mm by GetSet Surgical SA — 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-07640387660331 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- GetSet Surgical SA
- EUDAMED SRN
- CH-MF-000010244
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 1a52fb02-6e25-44ee-9395-bcef001cf722 61 fields · synced Jun 19, 2026
- FDA UDI ea9a09eb-bbd8-40ef-95a6-c3a69ba5f26e 34 fields · synced May 30, 2026