FDA.reportPublic FDA data

PTS

Primary DI
G616G190912DS0
Brand
PTS
Company
Pt. Solutions, LLC
Model
G1-909-12DS
Catalog number
G1-909-12DS
Device description
Sterile 12mm Distraction Screw, Gryphon
Published
2025-10-06
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
LYQAccessories, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYQAccessories, Fixation, Spinal Intervertebral BodyOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G616G190912DS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter12Millimeter

Regulatory Flags#

DUNS number
119209551
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G616RAFS102433060PRADO™ Lumbar Interbody Fusion SystemR-AFS-102433-06R-AFS-102433-062026-04-17
G616RAFS102433120PRADO™ Lumbar Interbody Fusion SystemR-AFS-102433-12R-AFS-102433-122026-04-17
G616RAFS102636060PRADO™ Lumbar Interbody Fusion SystemR-AFS-102636-06R-AFS-102636-062026-04-17
G616RAFS102636110PRADO™ Lumbar Interbody Fusion SystemR-AFS-102636-11AR-AFS-102636-11A2026-04-17
G616RAFS102636120PRADO™ Lumbar Interbody Fusion SystemR-AFS-102636-12R-AFS-102636-122026-04-17
G616RAFS102839060PRADO™ Lumbar Interbody Fusion SystemR-AFS-102839-06R-AFS-102839-062026-04-17
G616RAFS122433060PRADO™ Lumbar Interbody Fusion SystemR-AFS-122433-06R-AFS-122433-062026-04-17
G616RAFS122433120PRADO™ Lumbar Interbody Fusion SystemR-AFS-122433-12R-AFS-122433-122026-04-17
G616RAFS122636060PRADO™ Lumbar Interbody Fusion SystemR-AFS-122636-06R-AFS-122636-062026-04-17
G616RAFS122636110PRADO™ Lumbar Interbody Fusion SystemR-AFS-122636-11AR-AFS-122636-11A2026-04-17
G616RAFS122636120PRADO™ Lumbar Interbody Fusion SystemR-AFS-122636-12R-AFS-122636-122026-04-17
G616RAFS122839060PRADO™ Lumbar Interbody Fusion SystemR-AFS-122839-06R-AFS-122839-062026-04-17
G616RAFS142433060PRADO™ Lumbar Interbody Fusion SystemR-AFS-142433-06R-AFS-142433-062026-04-17
G616RAFS142433120PRADO™ Lumbar Interbody Fusion SystemR-AFS-142433-12R-AFS-142433-122026-04-17
G616RAFS142636060PRADO™ Lumbar Interbody Fusion SystemR-AFS-142636-06R-AFS-142636-062026-04-17
G616RAFS142636110PRADO™ Lumbar Interbody Fusion SystemR-AFS-142636-11AR-AFS-142636-11A2026-04-17
G616RAFS142636120PRADO™ Lumbar Interbody Fusion SystemR-AFS-142636-12R-AFS-142636-122026-04-17
G616RAFS142839060PRADO™ Lumbar Interbody Fusion SystemR-AFS-142839-06R-AFS-142839-062026-04-17
G616RAFS162433060PRADO™ Lumbar Interbody Fusion SystemR-AFS-162433-06R-AFS-162433-062026-04-17
G616RAFS162433120PRADO™ Lumbar Interbody Fusion SystemR-AFS-162433-12R-AFS-162433-122026-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493426709neoWave Lumbar, StraightXENIX MEDICAL LLCLYQ2026-04-29
00859373004029PasserEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004036HolderEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004043Symbol PlateEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004050DriverEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004067Tensioner ClipEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004074TensionerEMPIRICAL SPINE, INC.LYQ2026-03-27
00840493416441LUX Expandable Interbody SystemXENIX MEDICAL LLCLYQ2026-02-23
00840493416458LUX Expandable Interbody SystemXENIX MEDICAL LLCLYQ2026-02-23
00840493413952RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-12-02
00818345029590RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
00818345029606RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
00818345029620RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
00818345029637RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
00818345029644RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
G616G1090912DS1PTSPt. Solutions, LLCLYQ2025-10-06
G616G1090914DS1PTSPt. Solutions, LLCLYQ2025-10-06
G616G1090916DS1PTSPt. Solutions, LLCLYQ2025-10-06
G616G190914DS0PTSPt. Solutions, LLCLYQ2025-10-06
G616G190916DS0PTSPt. Solutions, LLCLYQ2025-10-06
00818345029583RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00818345029613RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00818345029934RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00818345029958RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00840493413747RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00840493413808RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00840493415413RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
G616S1090912DS1PTSPt. Solutions, LLCLYQ2025-03-10
G616S1090914DS1PTSPt. Solutions, LLCLYQ2025-03-10
G616S1090916DS1PTSPt. Solutions, LLCLYQ2025-03-10