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Tandry CMF Plate System T50-14005

by Microware Precision Co., Ltd.

Tandry CMF Plate System T50-14005 is a Class II device made by Microware Precision Co., Ltd., cleared under FDA 510(k) K220360 on 10 Nov 2022 and listed in FDA GUDID since 12 May 2026 (UDI-DI 04719873108251), 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) K220360

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 Number04719873108251 UDI-DI Date12 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220360 Date10 Nov 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220360 decided 10 Nov 2022 Active
  • FDA GUDID UDI-DI 04719873108251 listed 12 May 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220360
  2. Listed FDA GUDID 04719873108251

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tandry CMF Plate System
Generic name
Craniofacial bone screw, non-bioabsorbable
Model / reference
T50-14005
Primary DI / UDI-DI
04719873108251
510(k) Number
FDA product code
DZL
GMDN term
Craniofacial bone screw, non-bioabsorbable
Device class
Class II
Regulation number
872.4880
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K220360)

and 8 more cleared under K220360

Other devices from Microware Precision Co., Ltd.

See all devices from Microware Precision Co., Ltd. →

Properties

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