Tslp 489.440

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	Number10705034784489 UDI-DI	Date14 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK020244	Date22 Apr 2002Issued	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Withdrawn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: Tslp
Generic name: Spinal fixation plate, non-bioabsorbable
Model / Ref / Catalog: 489.440, 489440

Primary DI / UDI-DI: 10705034784489
510(k) Number: K020244
FDA product code: KWQ
GMDN term: Spinal fixation plate, non-bioabsorbable

Device class: Class II
Regulation number: 888.3060
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