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CarboClear Lumbar Cage System Slap Graft Hammer

by Carbofix Orthopedics Ltd

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 Number07290110206574 UDI-DI Date31 May 2020ListedStatusListed 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  • Withdrawn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 Lumbar Cage System
Generic Name
Surgical mallet
Model / Ref / Catalog
Slap Graft Hammer, CCLC9060
Description
A surgical tool used with the Implant Trials, if required, to assist in Trial removal from the disc space. May also be used for implant extraction.
Primary DI / UDI-DI
07290110206574
510(k) Number
FDA Product Code
MAX
GMDN Term
Surgical mallet
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical mallet

Cleared under the same submission (K193378)

Show all (12)

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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