FDA.reportPublic FDA data

GoPLF! Posterior Lateral Fusion Device

Primary DI
07640387660218
Brand
GoPLF! Posterior Lateral Fusion Device
Company
GetSet Surgical SA
Model
3200070
Device description
GoPLF! Posterior Lateral Fusion Device, 5.5mm x 70mm Curved Ti rods-2 per pack
Published
2023-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640387660218PrimaryGS10
07640387660621Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640387660218076403876602187640387660218
07640387660621076403876606217640387660621

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Regulatory Flags#

DUNS number
480143831
Device count
2
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

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