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CarboClear X Pedicle Screw System MIS Soft Tissue Dilator

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 Number07290117351291 UDI-DI Date19 Sep 2023ListedStatusListed 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  • Withdrawn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 X Pedicle Screw System
Generic Name
Open-surgery dissector
Model / Ref / Catalog
MIS Soft Tissue Dilator, MIS028
Primary DI / UDI-DI
07290117351291
510(k) Number
FDA Product Code
NKB, OLO, PML
GMDN Term
Open-surgery dissector
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: Open-surgery dissector

Cleared under the same submission (K231280)

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