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Kestrel® UT20

by INNO Holdings, Inc.

Kestrel® UT20 is a Class II device made by INNO Holdings, Inc., cleared under FDA 510(k) K181063 on 13 Jul 2018 and listed in FDA GUDID since 30 Sep 2018 (UDI-DI M711UT200), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

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) K181063

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 NumberM711UT200 UDI-DI Date30 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181063 Date13 Jul 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181063 decided 13 Jul 2018 Active
  • FDA GUDID UDI-DI M711UT200 listed 30 Sep 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181063
  2. Listed FDA GUDID M711UT200

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Kestrel®
Generic name
Spinal fixation plate, non-bioabsorbable
Model / Ref / Catalog
UT20
Primary DI / UDI-DI
M711UT200
FDA product code
KWQ
GMDN term
Spinal fixation plate, non-bioabsorbable
Device class
Class II
Regulation number
888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 20 Millimeter

Related devices

Category: Spinal fixation plate, non-bioabsorbable

Cleared under the same submission (K181063)

and 6 more cleared under K181063

Other devices from INNO Holdings, Inc.

See all devices from INNO Holdings, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)