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FaSet

by Dio Medical Co., Ltd. 227 variants

FaSet (FT.LN2.4540) is a device classified as Unclassified made by Dio Medical Co., Ltd., cleared under FDA 510(k) K180729 on 28 Jun 2018 and listed in FDA GUDID since 18 Mar 2021 (UDI-DI 08800113952355), active as of 22 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 22 Oct 2026

Documents

510(k) K180729

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800113952355 UDI-DI Date18 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180729 Date28 Jun 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180729 decided 28 Jun 2018 Active
  • FDA GUDID UDI-DI 08800113952355 listed 18 Mar 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180729
  2. Listed FDA GUDID 08800113952355

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Spinal fixation plate, non-bioabsorbable
Model / Ref / Catalog
A, FT.LN2.4540
Primary DI / UDI-DI
08800113952355
510(k) Number
FDA product code
MRW
GMDN term
Spinal fixation plate, non-bioabsorbable
Device class
U
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Related devices

Category: Spinal fixation plate, non-bioabsorbable

Cleared under the same submission (K180729)

and 8 more cleared under K180729

Similar devices

Other devices filed under FDA product code MRW (SYSTEM, FACET SCREW SPINAL DEVICE).

Other devices from Dio Medical Co., Ltd.

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  • IVA Cage

    Class II

  • Aeon-C

    Class II

See all devices from Dio Medical Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)