Pp-0345

by Biomet Microfixation, Inc

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

+2 more

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	Number00841036222864 UDI-DI	Date17 Nov 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK131674	Date8 Aug 2013Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK113512	Date29 Jun 2012Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK063052	Date12 Jan 2007Decided	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Withdrawn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 / reference: PP-0345

Primary DI / UDI-DI: 00841036222864
510(k) Number: K063052
K113512
K131674
FDA product code: LLZ, DZJ, JEY, HWC
GMDN term: Craniofacial fixation plate, non-bioabsorbable, non-customized

Device class: Class II
Regulation number: 892.2050, 872.4120, 872.4760, 888.3040
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

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

Other properties (10)

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
Manufacturing date: No