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CarboClear® Posterior Cervical Screw System

by Carbofix Orthopedics Ltd

510(k) K233989

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 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07290117354650 UDI-DI Date28 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK233989 Date27 Mar 2024ClearedStatusActive

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  • Withdrawn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 — FDA 510(k) Active

Specification

510(k) · GUDID

Generic Name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
Screw, CS4540
FDA applicant
CarboFix Orthopedics , Ltd.
Primary DI / UDI-DI
07290117354650
510(k) Number
FDA Product Code
NKG, ODP
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation
21 CFR Part 888.3075 510(k)GUDID
888.3080 GUDID
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
Size
Length — 40 Millimeter
Outer Diameter — 4.5 Millimeter

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Properties

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

Other properties (8)

  • 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