Skip to content

CarboClear Pedicle Screw System Patient Specific Curved Rod

by Carbofix Orthopedics Ltd GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290110208233 UDI-DIDate18 May 2021ListedStatusListed 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  • Withdrawn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
Bone-screw internal spinal fixation system rod
Model / Ref / Catalog
Patient Specific Curved Rod, SP0001
Primary DI / UDI-DI
07290110208233
510(k) Number
FDA Product Code
NKB
GMDN Term
Bone-screw internal spinal fixation system rod
Device Class
Class II
Regulation Number
888.3070
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone-screw internal spinal fixation system rod

Cleared under the same submission (K173487)

Show all (12)

Other devices from Carbofix Orthopedics Ltd

See all devices from Carbofix Orthopedics Ltd →

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