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FDA 510(k)

Alpine Cemented Hip System

K-Number: K153216 · 2016-02-18

Decision Date2016-02-18
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Alpine Cemented Hip System is a medical device manufactured by Ortho Development Corporation. It received FDA 510(k) clearance on 2016-02-18 under approval number K153216. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alpine Cemented Hip System?

Alpine Cemented Hip System is a medical device that received FDA 510(k) clearance on 2016-02-18. It is manufactured by Ortho Development Corporation. The 510(k) number is K153216.

When was Alpine Cemented Hip System approved by the FDA?

Alpine Cemented Hip System received FDA 510(k) clearance on 2016-02-18, under approval number K153216.

What company makes Alpine Cemented Hip System?

Alpine Cemented Hip System is manufactured by Ortho Development Corporation.

What is the FDA product code for Alpine Cemented Hip System?

The FDA product code for Alpine Cemented Hip System is JDI.

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Official Source

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