54-00650

by Stryker Leibinger

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 23 Oct 2026

Documents

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04546540237675 UDI-DI	Date16 Jun 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK983528	Date23 Dec 1998Decided	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Craniofacial fixation plate, non-bioabsorbable, non-customized
Model / Ref / Catalog: 54-00650

Primary DI / UDI-DI: 04546540237675
510(k) Number: K983528
FDA product code: JEY
GMDN term: Craniofacial fixation plate, non-bioabsorbable, non-customized

Device class: Class II
Regulation number: 872.4760
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Size: Length — 9.0 Centimeter
Width — 9.0 Centimeter
Length — 90.0 Millimeter
Width — 90.0 Millimeter

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Properties

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

Other properties (9)

Supplied 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