Cure LP 9-00011-31

by Meditech Spine, LLC

Cure LP 9-00011-31 is a Class II device made by Meditech Spine, LLC, cleared under FDA 510(k) K171538 on 16 Jun 2017 and listed in FDA GUDID since 6 Oct 2017 (UDI-DI B167900011310), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB167900011310 UDI-DI	Date6 Oct 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK171538	Date16 Jun 2017Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K171538

Across registries

2 registries list this device

FDA 510(k) K171538 decided 16 Jun 2017 Active
FDA GUDID UDI-DI B167900011310 listed 6 Oct 2017 Listed

Timeline

2 dated events

16 Jun 2017 Cleared FDA 510(k) K171538
6 Oct 2017 Listed FDA GUDID B167900011310

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Cure LP
Generic name: Spinal fixation plate, non-bioabsorbable
Model / reference: 9-00011-31

Primary DI / UDI-DI: B167900011310
510(k) Number: K171538
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, all answered No)