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CarboClear Posterior Cervical Screw System Hybrid Screw

by Carbofix Orthopedics Ltd 35 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 Number07290117356920 UDI-DI Date25 Mar 2026ListedStatusListed 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  • Withdrawn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
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
Hybrid Screw, HCS4022
Primary DI / UDI-DI
07290117356920
510(k) Number
FDA Product Code
NKG
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3075
GUDID distribution status
In Commercial Distribution
Size
Length — 22 Millimeter
Outer Diameter — 4.0 Millimeter

Related devices

Cleared under the same submission (K254045)

Show all (12)

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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