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Trumatch SD980.036

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 found

in data synced 23 Oct 2026

Documents

510(k) K243637

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05420060380860 UDI-DI Date11 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243637 Date21 Feb 2025DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
SD980.036
Primary DI / UDI-DI
05420060380860
510(k) Number
FDA product code
DZJ, LLZ
GMDN term
Custom-made organ/bone anatomy model/surgical guide kit
Device class
Class II
Regulation number
872.4120, 892.2050
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Custom-made organ/bone anatomy model/surgical guide kit

Cleared under the same submission (K243637)

Show all (12)

Other devices from Materialise NV

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Properties

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

Other properties (11)

  • 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
  • Manufacturing date: No