OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION)— 510(k) K964924

Substantially Equivalent

Osteoimplant Technology, Inc.

FDA 510(k) clearance K964924 for OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION), Substantially Equivalent on 1997-03-07. Applicant: Osteoimplant Technology, Inc..

Clearance details

Applicant: Osteoimplant Technology, Inc.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 1996-12-09
Decision date: 1997-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hunt Valley, MD, 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.