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Mitchell Ponseti® Bracing System UNIVERSAL MOUNT KIT

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 Number00810060888582 UDI-DI Date15 Dec 2025ListedStatusListed GUDID: in commercial distribution

Official records

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  • Withdrawn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
UNIVERSAL MOUNT KIT
Primary DI / UDI-DI
00810060888582
FDA product code
KNP
GMDN term
Ankle/foot orthosis
Device class
Class I
Regulation number
890.3475
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Other devices from MD Orthopaedics

See all devices from MD Orthopaedics →

Properties

  • Premarket exempt
  • Lot / batch number
  • Manufacturing date

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: 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