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CarboClear Posterior Cervical Screw System Drill Bit

by Carbofix Orthopedics Ltd 3 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290117351024 UDI-DI Date5 Jun 2024ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
CarboClear Posterior Cervical Screw System
Generic Name
Fluted surgical drill bit, single-use
Model / Ref / Catalog
Drill Bit, CS012
Primary DI / UDI-DI
07290117351024
510(k) Number
FDA Product Code
NKG, ODP
GMDN Term
Fluted surgical drill bit, single-use
Device Class
Class II
Regulation Number
888.3075, 888.3080
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 2.3 Millimeter

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Category: Fluted surgical drill bit, single-use

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No