MatrixNEURO 04.502.022

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 closed

Documents

None

No authorization documents

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10887587017525 UDI-DI	Date14 Sep 2015Listed	StatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

- Terminated Z-2698-2020 FDA Class II initiated 18 Jun 2020
One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: MatrixNEURO
Generic Name: Craniofacial fixation plate, non-bioabsorbable, non-customized
Model / Ref / Catalog: 04.502.022, 04502022

Primary DI / UDI-DI: 10887587017525
510(k) Number: K042365
K123723
FDA Product Code: JEY, GXR, GWO
GMDN Term: Craniofacial fixation plate, non-bioabsorbable, non-customized

Device Class: Class II
Regulation Number: 872.4760, 882.5250, 882.5320
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (10)

Sterile: 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