NEXFLEX TOTAL KNEE SYSTEM— 510(k) K991882

Substantially Equivalent

Nexmed, Inc.

FDA 510(k) clearance K991882 for NEXFLEX TOTAL KNEE SYSTEM, Substantially Equivalent on 1999-12-08. Applicant: Nexmed, Inc..

Clearance details

Applicant: Nexmed, Inc.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 1999-06-02
Decision date: 1999-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Desert, CA, US

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.