Pls-69T57

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	Number08033726405356 UDI-DI	Date3 Jul 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK081631	Date18 Jul 2008Decided	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Withdrawn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-69T57

Primary DI / UDI-DI: 08033726405356
510(k) Number: K081631
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