FDA UDI
In Commercial Distribution
🇺🇸 United States
GoLIF! Lumbar Interbody Fusion System
DI: 07640387660843
·
Model: 4020001
·
GetSet Surgical SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GoLIF! Lumbar Interbody Fusion System
- Primary DI
- 07640387660843
- Version / Model
- 4020001
- Company Name
- GetSet Surgical SA
- Labeler DUNS
- 480143831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-01
- Public Version
- 1
- Public Version Date
- 2025-04-09
- Public Version Status
- New
- Public Device Record Key
- 21fcc22a-bdd5-4706-a26d-5f65df5df82a
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61300 | Internal spinal fixation procedure kit, single-use | A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640387660843 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250186 | 000 |