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CarboClear Hybrid Pedicle Screw System Distractor-Compressor

by Carbofix Orthopedics Ltd GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290117358429 UDI-DIDate17 Nov 2025ListedStatusListed 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  • Withdrawn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 Hybrid Pedicle Screw System
Generic Name
Surgical implant handling forceps
Model / Ref / Catalog
Distractor-Compressor, HYB027
Primary DI / UDI-DI
07290117358429
510(k) Number
FDA Product Code
PML, NKB
GMDN Term
Surgical implant handling forceps
Device Class
Class II
Regulation Number
888.3027, 888.3070
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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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