KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP— 510(k) K020170

Substantially Equivalent

Encore Orthopedics, Inc.

FDA 510(k) clearance K020170 for KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP, Substantially Equivalent on 2002-02-11. Applicant: Encore Orthopedics, Inc..

Clearance details

Applicant: Encore Orthopedics, Inc.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2002-01-17
Decision date: 2002-02-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

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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.