UNISYN PLUS HIP STEM— 510(k) K120595

Substantially Equivalent

Consensus Orthopedics, Inc.

FDA 510(k) clearance K120595 for UNISYN PLUS HIP STEM, Substantially Equivalent on 2012-10-12. Applicant: Consensus Orthopedics, Inc..

Clearance details

Applicant: Consensus Orthopedics, Inc.
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 2012-02-28
Decision date: 2012-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado Hills, CA, US

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Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.