FDA.report

GoPLF! Posterior Lateral Fusion Device

Primary DI
07640387660546
Brand
GoPLF! Posterior Lateral Fusion Device
Company
GetSet Surgical SA
Model
3207555
Device description
GoPLF! Posterior Lateral Fusion Device, 2 Screws, Multi-Axial Titanium Screw, 7.5 x 55mm
Published
2023-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640387660133PrimaryGS10
07640387660546Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640387660133076403876601337640387660133
07640387660546076403876605467640387660546

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Sterilization Methods

Method

Regulatory Flags

DUNS number
480143831
Device count
2
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

Primary DIBrandModelCatalogPublished
07640387660270GoLIF! Lumbar Interbody Fusion System31022082025-04-01
07640387660287GoLIF! Lumbar Interbody Fusion System31022092025-04-01
07640387660294GoLIF! Lumbar Interbody Fusion System31022102025-04-01
07640387660300GoLIF! Lumbar Interbody Fusion System31022112025-04-01
07640387660317GoLIF! Lumbar Interbody Fusion System31022122025-04-01
07640387660324GoLIF! Lumbar Interbody Fusion System31022132025-04-01
07640387660331GoLIF! Lumbar Interbody Fusion System31022142025-04-01
07640387660348GoLIF! Lumbar Interbody Fusion System31026082025-04-01
07640387660355GoLIF! Lumbar Interbody Fusion System31026092025-04-01
07640387660362GoLIF! Lumbar Interbody Fusion System31026102025-04-01
07640387660379GoLIF! Lumbar Interbody Fusion System31026112025-04-01
07640387660386GoLIF! Lumbar Interbody Fusion System31026122025-04-01
07640387660393GoLIF! Lumbar Interbody Fusion System31026132025-04-01
07640387660409GoLIF! Lumbar Interbody Fusion System31026142025-04-01
07640387660843GoLIF! Lumbar Interbody Fusion System40200012025-04-01
07640387660850GoLIF! Lumbar Interbody Fusion System40200022025-04-01
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

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