Identity
- Trade Name
- GoPLF! Core Set EUDAMEDGoPLF! Posterior Lateral Fusion System FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, single-use FDA UDI
- Device Name
- GoPLF! Posterior Lateral Fusion System Core Set EUDAMEDThe GoPLF! Core instrument set contains instruments numbered 1 – 9 that are placed in chronological order within the tray, for an efficient surgical procedure of the GoPLF! Posterior Lateral Fusion Device (system-specific instruments) FDA UDI
- Model / Reference
- 4010001 EUDAMEDFDA UDI
- Description
- The GoPLF! Core instrument set contains instruments numbered 1 – 9 that are placed in chronological order within the tray, for an efficient surgical procedure of the GoPLF! Posterior Lateral Fusion Device (system-specific instruments) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640387660829 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640387660829 EUDAMED
- FDA Product Code
- NKB 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
- 888.3070 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
GoPLF! Core Set by GetSet Surgical SA — Class IIa — 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-07640387660829 | 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 8e95692f-2bf7-43ff-a40f-adbf2f7b5016 61 fields · synced Jul 31, 2026
- FDA UDI bb793002-7f5a-4f87-9235-04becf270411 33 fields · synced May 30, 2026