Lospa Modular Knee System KB.SFT.E14L

by Corentec Co., Ltd

Lospa Modular Knee System KB.SFT.E14L is a Class II device made by Corentec Co., Ltd, cleared under FDA 510(k) K222278 on 26 Aug 2022 and listed in FDA GUDID since 11 Feb 2025 (UDI-DI 08800068980090), 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	Number08800068980090 UDI-DI	Date11 Feb 2025Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK222278	Date26 Aug 2022Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08800068980090
FDA 510(k) database 510(k) number K222278

Across registries

2 registries list this device

FDA 510(k) K222278 decided 26 Aug 2022 Active
FDA GUDID UDI-DI 08800068980090 listed 11 Feb 2025 Listed

Timeline

2 dated events

26 Aug 2022 Cleared FDA 510(k) K222278
11 Feb 2025 Listed FDA GUDID 08800068980090

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Lospa Modular Knee System
Generic name: Knee femur prosthesis trial, reusable
Model / reference: KB.SFT.E14L

Primary DI / UDI-DI: 08800068980090
510(k) Number: K222278
FDA product code: JWH
GMDN term: Knee femur prosthesis trial, reusable

Device class: Class II
Regulation number: 888.3560
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Corentec Co., Ltd

See all devices from Corentec Co., Ltd →

Properties

Sterilise before use
Prescription use
Lot / batch number
Manufacturing date

Other properties (11, all answered No)