LapiLock CD-LL-9001

by Fusion Orthopedics, LLC

LapiLock CD-LL-9001 is a Class II device made by Fusion Orthopedics, LLC, cleared under FDA 510(k) K202959 on 24 Nov 2020 and listed in FDA GUDID since 19 May 2022 (UDI-DI 00840124506565), 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	Number00840124506565 UDI-DI	Date19 May 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK202959	Date24 Nov 2020Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00840124506565
FDA 510(k) database 510(k) number K202959

Across registries

2 registries list this device

FDA 510(k) K202959 decided 24 Nov 2020 Active
FDA GUDID UDI-DI 00840124506565 listed 19 May 2022 Listed

Timeline

2 dated events

24 Nov 2020 Cleared FDA 510(k) K202959
19 May 2022 Listed FDA GUDID 00840124506565

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: LapiLock
Generic name: Surgical saw blade, oscillating, single-use
Model / Ref / Catalog: CD-LL-9001

Primary DI / UDI-DI: 00840124506565
510(k) Number: K202959
FDA product code: HWC
GMDN term: Surgical saw blade, oscillating, single-use

Device class: Class II
Regulation number: 888.3040
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Fusion Orthopedics USA, LLC

See all devices from Fusion Orthopedics USA, LLC →

Properties

Sterilise before use
Single use
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (9, all answered No)