FDA.reportPublic FDA data

Dark Star Deformity

Primary DI
B0751002490
Brand
Dark Star Deformity
Company
Republic Spine, LLC
Model
100249
Catalog number
DS0003
Device description
Screw Height Positioner
Published
2025-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0751002490PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
561-334-2421james@rspine.com

Regulatory Flags#

DUNS number
061891717
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B075102001400Dark Star Navigation102001-40DSN-40T2026-05-14
B07511002428S0606T0Restore Lumbar Interbody Fusion System110024-28S0606TRETL-28S0606T2026-01-14
B07511002428S0706T0Restore Lumbar Interbody Fusion System110024-28S0706TRETL-28S0706T2026-01-14
B07511002428S0806T0Restore Lumbar Interbody Fusion System110024-28S0806TRETL-28S0806T2026-01-14
B07511002428S0906T0Restore Lumbar Interbody Fusion System110024-28S0906TRETL-28S0906T2026-01-14
B07511002428S1006T0Restore Lumbar Interbody Fusion System110024-28S1006TRETL-28S1006T2026-01-14
B07511002428S1106T0Restore Lumbar Interbody Fusion System110024-28S1106TRETL-28S1106T2026-01-14
B07511002428S1206T0Restore Lumbar Interbody Fusion System110024-28S1206TRETL-28S1206T2026-01-14
B07511002428S1306T0Restore Lumbar Interbody Fusion System110024-28S1306TRETL-28S1306T2026-01-14
B07511002428S1406T0Restore Lumbar Interbody Fusion System110024-28S1406TRETL-28S1406T2026-01-14
B07511002428S1506T0Restore Lumbar Interbody Fusion System110024-28S1506TRETL-28S1506T2026-01-14
B07510000875700Dark Star Deformity100008-7570DSDA-75702025-11-18
B0751000490Dark Star Deformity100049DS00252025-11-18
B0751000530Dark Star Deformity100053DS00262025-11-18
B075100054L0Dark Star Deformity100054-01DT004T-L2025-11-18
B0751001300Dark Star Deformity100130DS00342025-11-18
B0751001370Dark Star Deformity100137DS00392025-11-18
B075100187010Dark Star Deformity100187-01DS0001-C2025-11-18
B075100187020Dark Star Deformity100187-02DS0001-CL2025-11-18
B0751001970Dark Star Deformity100197DS00372025-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
M719GL3110TiLockGenesys Orthopedics Systems LLCNKB2026-08-03
M719GLC403S0TiLockGenesys Orthopedics Systems LLCNKB2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCNKB2026-08-03
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-08-02
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-08-02
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-30
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-30
00840493425382RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425399RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425405RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425412RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425429RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28