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CarboClear Posterior Cervical Screw System Adjustable Drill Guide

by Carbofix Orthopedics Ltd GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290117350973 UDI-DIDate5 Jun 2024ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
CarboClear Posterior Cervical Screw System
Generic Name
Surgical drill guide, reusable
Model / Ref / Catalog
Adjustable Drill Guide, CS007
Primary DI / UDI-DI
07290117350973
510(k) Number
FDA Product Code
NKG, ODP
GMDN Term
Surgical drill guide, reusable
Device Class
Class II
Regulation Number
888.3075, 888.3080
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical drill guide, reusable

Cleared under the same submission (K233989)

Show all (12)

Other devices from Carbofix Orthopedics Ltd

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • 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