FDA.report

GoLIF! Lumbar Interbody Fusion System

Primary DI
07640387660843
Brand
GoLIF! Lumbar Interbody Fusion System
Company
GetSet Surgical SA
Model
4020001
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.
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

Related Records

Product Codes

CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions

SubmissionSupplement
K250186000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K250186000GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA2025-03-21MAX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640387660843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640387660843076403876608437640387660843

GMDN Terms

TermDefinition
Internal spinal fixation procedure kit, single-useA 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.

Sterilization Methods

Method

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
false
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

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07640387660294GoLIF! Lumbar Interbody Fusion System31022102025-04-01
07640387660300GoLIF! Lumbar Interbody Fusion System31022112025-04-01
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07640387660379GoLIF! Lumbar Interbody Fusion System31026112025-04-01
07640387660386GoLIF! Lumbar Interbody Fusion System31026122025-04-01
07640387660393GoLIF! Lumbar Interbody Fusion System31026132025-04-01
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07640387660478GoPLF! Posterior Lateral Fusion Device32065452023-12-12
07640387660485GoPLF! Posterior Lateral Fusion Device32065502023-12-12
07640387660492GoPLF! Posterior Lateral Fusion Device32065552023-12-12
07640387660508GoPLF! Posterior Lateral Fusion Device32075352023-12-12
07640387660515GoPLF! Posterior Lateral Fusion Device32075402023-12-12

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