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Smart Correction 31-700-21006UA-0

by Wishbone Medical Inc.

Smart Correction 31-700-21006UA-0 is a Class II device made by Wishbone Medical Inc., cleared under FDA 510(k) K221366 on 6 Jun 2022 and listed in FDA GUDID since 19 Jul 2022 (UDI-DI B5623170021006UA00), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K221366

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB5623170021006UA00 UDI-DI Date19 Jul 2022ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK221366 Date6 Jun 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221366 decided 6 Jun 2022 Active
  • FDA GUDID UDI-DI B5623170021006UA00 listed 19 Jul 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K221366
  2. Listed FDA GUDID B5623170021006UA00

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Smart Correction
Generic name
External orthopaedic fixation system, single-use
Model / Ref / Catalog
31-700-21006UA-0
Primary DI / UDI-DI
B5623170021006UA00
510(k) Number
FDA product code
KTT
GMDN term
External orthopaedic fixation system, single-use
Device class
Class II
Regulation number
888.3030
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Wishbone Medical Inc.

See all devices from Wishbone Medical Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)