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CarboClear Pedicle Screw System Probe - Pointed, Curved

by Carbofix Orthopedics Ltd GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290109338873 UDI-DIDate23 Jul 2018ListedStatusListed 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  • Withdrawn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 Pedicle Screw System
Generic Name
General internal orthopaedic fixation system implantation kit
Model / Ref / Catalog
Probe - Pointed, Curved, PPS922390
Primary DI / UDI-DI
07290109338873
510(k) Number
FDA Product Code
NKB
GMDN Term
General internal orthopaedic fixation system implantation kit
Device Class
Class II
Regulation Number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: General internal orthopaedic fixation system implantation kit

Cleared under the same submission (K173487)

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