HOWMEDICA MAINSTAY ANCHOR— 510(k) K953531

Substantially Equivalent for Some Indications

Howmedica Corp.

FDA 510(k) clearance K953531 for HOWMEDICA MAINSTAY ANCHOR, Substantially Equivalent for Some Indications on 1995-09-26. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 1995-07-27
Decision date: 1995-09-26
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Rutherford, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.