ENCOMPASS 10/12 HIP STEM— 510(k) K132697

Substantially Equivalent

Ortho Development Corp.

FDA 510(k) clearance K132697 for ENCOMPASS 10/12 HIP STEM, Substantially Equivalent on 2014-06-20. Applicant: Ortho Development Corp..

Clearance details

Applicant: Ortho Development Corp.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2013-08-29
Decision date: 2014-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, 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.