APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)— 510(k) K112779

Substantially Equivalent

Omnlife Science

FDA 510(k) clearance K112779 for APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM), Substantially Equivalent on 2011-12-02. Applicant: Omnlife Science.

Clearance details

Applicant: Omnlife Science
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2011-09-26
Decision date: 2011-12-02
Decision: Substantially Equivalent
Clearance type: Special
Location: East Taunton, MA, 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.