Trumatch SD980.055

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

2 closed

Documents

+3 more

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number05420060351372 UDI-DI	Date22 Oct 2026Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK260913	Date9 Oct 2026Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK253308	Date7 Jan 2026Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK243637	Date21 Feb 2025Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK170272	Date8 Aug 2017Decided	StatusActive

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

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Withdrawn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: SD980.055

Primary DI / UDI-DI: 05420060351372
510(k) Number: K170272
K243637
K253308
K260913
FDA product code: LLZ, PPT, DZJ, JEY
GMDN term: Custom-made organ/bone anatomy model/surgical guide kit

Device class: Class II
Regulation number: 892.2050, 882.4310, 872.4120, 872.4760
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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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