Identity
- Trade Name
- GoLIF! Core Set EUDAMEDGoLIF! Lumbar Interbody Fusion System FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, single-use FDA UDI
- Device Name
- GoLIF! Lumbar Interbody Fusion System Core Set EUDAMEDThe GoLIF! Core instrument set contains instruments that are placed in chronological order within the tray, for an efficient surgical procedure of the above implants. The 3-in-1 instruments are available in sizes 8mm – 14mm in 1mm increments. FDA UDI
- Model / Reference
- 4020001 EUDAMEDFDA UDI
- Description
- The GoLIF! Core instrument set contains instruments that are placed in chronological order within the tray, for an efficient surgical procedure of the above implants. The 3-in-1 instruments are available in sizes 8mm – 14mm in 1mm increments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640387660843 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640387660843 EUDAMED
- 510(k) Number
- K250186 FDA UDI
- FDA Product Code
- MAX FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Internal spinal fixation procedure kit, single-use FDA UDI
Classification
- Device Class
- Class IIa 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
No
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
Category: Joint prosthesis implantation kit, single-use
GoLIF! Core Set by GetSet Surgical SA — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-07640387660843 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 5574b388-e129-4964-8f82-23e39aca495b 61 fields · synced Jul 24, 2026
- FDA UDI 21fcc22a-bdd5-4706-a26d-5f65df5df82a 34 fields · synced May 30, 2026