FDA.reportPublic FDA data

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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250186000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640387660843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640387660843076403876608437640387660843

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
480143831
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640387660140GoPLF! Posterior Lateral Fusion Device31000102023-12-12
07640387660003GoPLF! Posterior Lateral Fusion Device32055352022-02-21
07640387660010GoPLF! Posterior Lateral Fusion Device32055402022-02-21
07640387660027GoPLF! Posterior Lateral Fusion Device32055452022-02-21
07640387660034GoPLF! Posterior Lateral Fusion Device32055502022-02-21
07640387660041GoPLF! Posterior Lateral Fusion Device32065352022-02-21
07640387660058GoPLF! Posterior Lateral Fusion Device32065402022-02-21
07640387660065GoPLF! Posterior Lateral Fusion Device32065452023-12-12
07640387660072GoPLF! Posterior Lateral Fusion Device32065502023-12-12
07640387660089GoPLF! Posterior Lateral Fusion Device32065552023-12-12
07640387660096GoPLF! Posterior Lateral Fusion Device32075352023-12-12
07640387660102GoPLF! Posterior Lateral Fusion Device32075402023-12-12
07640387660119GoPLF! Posterior Lateral Fusion Device32075452023-12-12
07640387660126GoPLF! Posterior Lateral Fusion Device32075502023-12-12
07640387660133GoPLF! Posterior Lateral Fusion Device32075552023-12-12
07640387660157GoPLF! Posterior Lateral Fusion Device32000352023-12-12
07640387660164GoPLF! Posterior Lateral Fusion Device32000402023-12-12
07640387660171GoPLF! Posterior Lateral Fusion Device32000452023-12-12
07640387660188GoPLF! Posterior Lateral Fusion Device32000502023-12-12
07640387660195GoPLF! Posterior Lateral Fusion Device32000552023-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043912870N/ATDM Co., Ltd.MAX2026-06-02
08800043912887N/ATDM Co., Ltd.MAX2026-06-02
08800043912894N/ATDM Co., Ltd.MAX2026-06-02
08800043912900N/ATDM Co., Ltd.MAX2026-06-02
08800043912917N/ATDM Co., Ltd.MAX2026-06-02
08800043912924N/ATDM Co., Ltd.MAX2026-06-02
08800043912931N/ATDM Co., Ltd.MAX2026-06-02
08800043912948N/ATDM Co., Ltd.MAX2026-06-02
08800043912955N/ATDM Co., Ltd.MAX2026-06-02
08800043912962N/ATDM Co., Ltd.MAX2026-06-02
08800043912979N/ATDM Co., Ltd.MAX2026-06-02
08800043912986N/ATDM Co., Ltd.MAX2026-06-02
08800043912993N/ATDM Co., Ltd.MAX2026-06-02
08800043913006N/ATDM Co., Ltd.MAX2026-06-02
08800043913013N/ATDM Co., Ltd.MAX2026-06-02
08800043913020N/ATDM Co., Ltd.MAX2026-06-02
08800043913037N/ATDM Co., Ltd.MAX2026-06-02
08800043913044N/ATDM Co., Ltd.MAX2026-06-02
08800043913051N/ATDM Co., Ltd.MAX2026-06-02
08800043913068N/ATDM Co., Ltd.MAX2026-06-02
08800043913075N/ATDM Co., Ltd.MAX2026-06-02
08800043964183N/ATDM Co., Ltd.MAX2026-06-02
08800043964190N/ATDM Co., Ltd.MAX2026-06-02
08800043964206N/ATDM Co., Ltd.MAX2026-06-02
08800043964213N/ATDM Co., Ltd.MAX2026-06-02
08800043964220N/ATDM Co., Ltd.MAX2026-06-02
08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02
08800043964268N/ATDM Co., Ltd.MAX2026-06-02