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Dark Star Deformity 100206

by Republic Spine, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB0751002060 UDI-DI Date18 Nov 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Dark Star Deformity
Generic name
General internal orthopaedic fixation system implantation kit
Model / Ref / Catalog
100206, DS0004
Primary DI / UDI-DI
B0751002060
FDA product code
NKB, KWP
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class II
Regulation number
888.3070, 888.3050
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Other devices from Republic Spine, LLC

See all devices from Republic Spine, LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No