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TruMatch SD980.009

by Materialise NV

TruMatch SD980.009 is a Class II device made by Materialise NV, cleared under FDA 510(k) K170272 on 8 Aug 2017 and listed in FDA GUDID since 31 Aug 2017 (UDI-DI 05420060380099), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K170272

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 Number05420060380099 UDI-DI Date31 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170272 Date8 Aug 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170272 decided 8 Aug 2017 Active
  • FDA GUDID UDI-DI 05420060380099 listed 31 Aug 2017 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1484-2020 FDA Class II initiated 3 Feb 2020
    • Terminated Z-1485-2020 FDA Class II initiated 3 Feb 2020

    Custom surgical kits contain a plate different than indicated by the package labeling.

Timeline

4 dated events

  1. Cleared FDA 510(k) K170272
  2. Listed FDA GUDID 05420060380099
  3. Recall initiated FDA recalls Z-1484-2020
  4. Recall initiated FDA recalls Z-1485-2020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TruMatch
Generic name
Craniofacial fixation plate kit, non-bioabsorbable
Model / Ref / Catalog
SD980.009
Primary DI / UDI-DI
05420060380099
510(k) Number
FDA product code
JEY
GMDN term
Craniofacial fixation plate kit, non-bioabsorbable
Device class
Class II
Regulation number
872.4760
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Craniofacial fixation plate kit, non-bioabsorbable

Cleared under the same submission (K170272)

and 8 more cleared under K170272

Similar devices

Other devices filed under FDA product code JEY (Plate, Bone).

Other devices from Materialise NV

See all devices from Materialise NV →

Properties

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