FDA.reportPublic FDA data

Dark Star Deformity

Primary DI
B075101191650
Brand
Dark Star Deformity
Company
Republic Spine, LLC
Model
101191-65
Catalog number
DSD-F65T
Device description
Triple Lead Fine Screw Tap - Ø6.5mm
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223096000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223096000Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC2023-05-26NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B075101191650PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter6.5Millimeter

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

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