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Dark Star Deformity 101200

by Republic Spine, LLC

Dark Star Deformity 101200 (DS0078-R) is a Class II device made by Republic Spine, LLC, cleared under FDA 510(k) K223096 on 26 May 2023 and listed in FDA GUDID since 18 Nov 2025 (UDI-DI B0751012000), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K223096

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB0751012000 UDI-DI Date18 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK223096 Date26 May 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223096 decided 26 May 2023 Active
  • FDA GUDID UDI-DI B0751012000 listed 18 Nov 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K223096
  2. Listed FDA GUDID B0751012000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dark Star Deformity
Generic name
Manual orthopaedic bender, reusable
Model / Ref / Catalog
101200, DS0078-R
Primary DI / UDI-DI
B0751012000
510(k) Number
FDA product code
NKB, KWP
GMDN term
Manual orthopaedic bender, reusable
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

Related devices

Cleared under the same submission (K223096)

and 8 more cleared under K223096

Other devices from Republic Spine, LLC

See all devices from Republic Spine, LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)