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CarboClear X Pedicle Screw System MIS Sterilization Box

by Carbofix Orthopedics Ltd GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290117350904 UDI-DIDate28 Aug 2023ListedStatusListed 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  • Withdrawn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 X Pedicle Screw System
Generic Name
Surgical instrument/implant rack
Model / Ref / Catalog
MIS Sterilization Box, MIS101
Primary DI / UDI-DI
07290117350904
510(k) Number
FDA Product Code
NKB, OLO, PML
GMDN Term
Surgical instrument/implant rack
Device Class
Class II
Regulation Number
888.3070, 882.4560, 888.3027
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical instrument/implant rack

Cleared under the same submission (K231280)

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