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Smart Correction 11-705-445151S

by Wishbone Medical Inc.

Smart Correction 11-705-445151S is a Class II device made by Wishbone Medical Inc., cleared under FDA 510(k) K231461 on 16 Jun 2023 and listed in FDA GUDID since 22 Jun 2023 (UDI-DI B56211705445151S0), 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) K231461

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 NumberB56211705445151S0 UDI-DI Date22 Jun 2023ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK231461 Date16 Jun 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231461 decided 16 Jun 2023 Active
  • FDA GUDID UDI-DI B56211705445151S0 listed 22 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K231461
  2. Listed FDA GUDID B56211705445151S0

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  • Withdrawn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
11-705-445151S
Primary DI / UDI-DI
B56211705445151S0
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
MRI safety
MR Unsafe

Other devices from Wishbone Medical Inc.

See all devices from Wishbone Medical Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)