APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010— 510(k) K101575

Substantially Equivalent

Omnlife Science

FDA 510(k) clearance K101575 for APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010, Substantially Equivalent on 2010-06-30. Applicant: Omnlife Science.

Clearance details

Applicant: Omnlife Science
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2010-06-07
Decision date: 2010-06-30
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.