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FDA 510(k)

DJO Acetabular System

K-Number: K190057 · 2019-06-07

Decision Date2019-06-07
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DJO Acetabular System is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2019-06-07 under approval number K190057. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DJO Acetabular System?

DJO Acetabular System is a medical device that received FDA 510(k) clearance on 2019-06-07. It is manufactured by Encore Medical L.P.. The 510(k) number is K190057.

When was DJO Acetabular System approved by the FDA?

DJO Acetabular System received FDA 510(k) clearance on 2019-06-07, under approval number K190057.

What company makes DJO Acetabular System?

DJO Acetabular System is manufactured by Encore Medical L.P..

What is the FDA product code for DJO Acetabular System?

The FDA product code for DJO Acetabular System is LPH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.