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Trumatch SD980.041

by Materialise NV

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

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05420060351235 UDI-DI Date22 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK260913 Date9 Oct 2026DecidedStatusActive

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.

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  • Withdrawn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
Custom-made organ/bone anatomy model/surgical guide kit
Model / Ref / Catalog
SD980.041
Primary DI / UDI-DI
05420060351235
510(k) Number
FDA product code
JEY, DZJ, LLZ
GMDN term
Custom-made organ/bone anatomy model/surgical guide kit
Device class
Class II
Regulation number
872.4760, 872.4120, 892.2050
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K170272)

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Cleared under the same submission (K243637)

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Cleared under the same submission (K260913)

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Other devices from Materialise NV

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Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date

Other properties (10)

  • Supplied sterile: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No