GoLIF! Lumbar Interbody Fusion System
- Primary DI
- 07640387660324
- Brand
- GoLIF! Lumbar Interbody Fusion System
- Company
- GetSet Surgical SA
- Model
- 3102213
- Device description
- GoLIF! Lumbar Interbody Fusion Device, 1 PEEK polymers cage 22mm x 13mm
- Published
- 2025-04-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K250186 | 000 | GoLIF! Lumbar Interbody Fusion System | Getset Surgical, SA | 2025-03-21 | MAX |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 07640387660324 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 07640387660324 | 07640387660324 | 7640387660324 |
GMDN Terms
| Term | Definition |
|---|
| Polymeric spinal interbody fusion cage | A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device. |
Regulatory Flags
- DUNS number
- 480143831
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 07640387660270 | GoLIF! Lumbar Interbody Fusion System | 3102208 | | 2025-04-01 |
| 07640387660287 | GoLIF! Lumbar Interbody Fusion System | 3102209 | | 2025-04-01 |
| 07640387660294 | GoLIF! Lumbar Interbody Fusion System | 3102210 | | 2025-04-01 |
| 07640387660300 | GoLIF! Lumbar Interbody Fusion System | 3102211 | | 2025-04-01 |
| 07640387660317 | GoLIF! Lumbar Interbody Fusion System | 3102212 | | 2025-04-01 |
| 07640387660331 | GoLIF! Lumbar Interbody Fusion System | 3102214 | | 2025-04-01 |
| 07640387660348 | GoLIF! Lumbar Interbody Fusion System | 3102608 | | 2025-04-01 |
| 07640387660355 | GoLIF! Lumbar Interbody Fusion System | 3102609 | | 2025-04-01 |
| 07640387660362 | GoLIF! Lumbar Interbody Fusion System | 3102610 | | 2025-04-01 |
| 07640387660379 | GoLIF! Lumbar Interbody Fusion System | 3102611 | | 2025-04-01 |
| 07640387660386 | GoLIF! Lumbar Interbody Fusion System | 3102612 | | 2025-04-01 |
| 07640387660393 | GoLIF! Lumbar Interbody Fusion System | 3102613 | | 2025-04-01 |
| 07640387660409 | GoLIF! Lumbar Interbody Fusion System | 3102614 | | 2025-04-01 |
| 07640387660843 | GoLIF! Lumbar Interbody Fusion System | 4020001 | | 2025-04-01 |
| 07640387660850 | GoLIF! Lumbar Interbody Fusion System | 4020002 | | 2025-04-01 |
| 07640387660478 | GoPLF! Posterior Lateral Fusion Device | 3206545 | | 2023-12-12 |
| 07640387660485 | GoPLF! Posterior Lateral Fusion Device | 3206550 | | 2023-12-12 |
| 07640387660492 | GoPLF! Posterior Lateral Fusion Device | 3206555 | | 2023-12-12 |
| 07640387660508 | GoPLF! Posterior Lateral Fusion Device | 3207535 | | 2023-12-12 |
| 07640387660515 | GoPLF! Posterior Lateral Fusion Device | 3207540 | | 2023-12-12 |
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