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LOSPA Knee System 01.61.183

by Corentec Co., Ltd

LOSPA Knee System 01.61.183 is a Class II device made by Corentec Co., Ltd, cleared under FDA 510(k) K130673 on 15 Apr 2013 (2 earlier submissions) and listed in FDA GUDID since 30 Nov 2018 (UDI-DI 08806373889783), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08806373889783 UDI-DI Date30 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK130673 Date15 Apr 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130673 decided 15 Apr 2013 Active· +2 more in the status table
  • FDA GUDID UDI-DI 08806373889783 listed 30 Nov 2018 Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1935-2024 FDA Class II initiated 29 Mar 2024
    • Ongoing Z-1934-2024 FDA Class II initiated 29 Mar 2024

    Due to unsupported 10 year expiration date.

Timeline

6 dated events

  1. Cleared FDA 510(k) K110404
  2. Cleared FDA 510(k) K121037
  3. Cleared FDA 510(k) K130673
  4. Listed FDA GUDID 08806373889783
  5. Recall initiated FDA recalls Z-1935-2024
  6. Recall initiated FDA recalls Z-1934-2024

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
LOSPA Knee System
Generic name
Orthopaedic broach
Model / reference
01.61.183
Primary DI / UDI-DI
08806373889783
510(k) Number
FDA product code
JWH
GMDN term
Orthopaedic broach
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic broach

Cleared under the same submission (K110404)

and 8 more cleared under K110404

Cleared under the same submission (K121037)

and 8 more cleared under K121037

Similar devices in this category

Other devices filed under Orthopaedic broach.

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)