Skip to content

Mitchell Ponseti® Bracing System HDWEKIT

by MD Orthopaedics

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00810060888438 UDI-DI Date12 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Mitchell Ponseti® Bracing System
Generic Name
Ankle/foot orthosis
Model / Reference
HDWEKIT
Primary DI / UDI-DI
00810060888438
FDA Product Code
ITN
GMDN Term
Ankle/foot orthosis
Device Class
Class I
Regulation Number
890.3675
GUDID distribution status
In Commercial Distribution

Other devices from MD Orthopaedics

See all devices from MD Orthopaedics →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No