Pls-10095T56

by Sintea Plustek, LLC

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	Number08057432563445 UDI-DI	Date12 Jan 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK112611	Date25 Apr 2012Decided	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Withdrawn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

Trade name: Pls
Generic name: Trans-facet-screw internal spinal fixation system, sterile
Model / reference: PLS-10095T56

Primary DI / UDI-DI: 08057432563445
510(k) Number: K112611
FDA product code: KWP
GMDN term: Trans-facet-screw internal spinal fixation system, sterile

Device class: Class II
Regulation number: 888.3050
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization
MRI safety: MR Unsafe

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Properties

Sterilise before use
Single use
Lot / batch number

Other properties (12)

Supplied sterile: No
Implantable: No
Contains latex: No
Prescription use: 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