LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation— 510(k) K222278

Substantially Equivalent

Corentec Co., Ltd.

FDA 510(k) clearance K222278 for LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation, Substantially Equivalent on 2022-08-26. Applicant: Corentec Co., Ltd..

Clearance details

Applicant: Corentec Co., Ltd.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2022-07-29
Decision date: 2022-08-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Cheonan-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.