DEPUY ACE COMPOSITE LOCKING NUT— 510(k) K983265

Substantially Equivalent

Depuy Ace Medical Co.

FDA 510(k) clearance K983265 for DEPUY ACE COMPOSITE LOCKING NUT, Substantially Equivalent on 1998-10-26. Applicant: Depuy Ace Medical Co..

Clearance details

Applicant: Depuy Ace Medical Co.
Product code: Code HTN
Advisory panel: Orthopedic
Date received: 1998-09-17
Decision date: 1998-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Segundo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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.