RESTORATION ACETABULAR WEDGE AUGMENTS— 510(k) K102019

Substantially Equivalent

Howmedica Osteonics

FDA 510(k) clearance K102019 for RESTORATION ACETABULAR WEDGE AUGMENTS, Substantially Equivalent on 2011-03-03. Applicant: Howmedica Osteonics.

Clearance details

Applicant: Howmedica Osteonics
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2010-07-19
Decision date: 2011-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, 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.