REVELATION POROUS HIP STEM— 510(k) K994070

Substantially Equivalent

Encore Orthopedics, Inc.

FDA 510(k) clearance K994070 for REVELATION POROUS HIP STEM, Substantially Equivalent on 2000-01-20. Applicant: Encore Orthopedics, Inc..

Clearance details

Applicant: Encore Orthopedics, Inc.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 1999-12-02
Decision date: 2000-01-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.