TRITON HIP SYSTEM— 510(k) K003649

Substantially Equivalent

Hayes Medical, Inc.

FDA 510(k) clearance K003649 for TRITON HIP SYSTEM, Substantially Equivalent on 2001-02-23. Applicant: Hayes Medical, Inc..

Clearance details

Applicant: Hayes Medical, Inc.
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 2000-11-27
Decision date: 2001-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado Hills, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.