FDA.reportPublic FDA data

Dark Star Navigation

Primary DI
B075102001400
Brand
Dark Star Navigation
Company
Republic Spine, LLC
Model
102001-40
Catalog number
DSN-40T
Device description
Dark Star Navigation Triple Lead Tap - Ø4.0mm
Published
2026-05-14
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212028000Dark Star Navigation Instrument SystemRepublic Spine, LLC2021-09-27OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B075102001400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4Millimeter

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
B0751002060Dark Star Deformity100206DS00042025-11-18

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