MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS— 510(k) K112158

Name: FDA 510(k) clearance K112158
Creator: U.S. Food and Drug Administration
Published: 2012-05-10

Substantially Equivalent

Lima Corporate S.P.A.

FDA 510(k) clearance K112158 for MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS, Substantially Equivalent on 2012-05-10. Applicant: Lima Corporate S.P.A.. Device class: 2.

Clearance details

Applicant: Lima Corporate S.P.A.
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2011-07-27
Decision date: 2012-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winona Lake, IN, US

Download summary PDF View on FDA.gov ↗

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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.