FDA 510(k)

REVELATION POROUS COATED HIP STEM, SIZE 8

K-Number: K122636 · 2012-11-02

Decision Date2012-11-02

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

REVELATION POROUS COATED HIP STEM, SIZE 8 is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2012-11-02 under 510(k) number K122636. 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 REVELATION POROUS COATED HIP STEM, SIZE 8?

REVELATION POROUS COATED HIP STEM, SIZE 8 is a medical device that received FDA 510(k) clearance on 2012-11-02. The listed applicant is Encore Medical L.P.. The 510(k) number is K122636.

When did REVELATION POROUS COATED HIP STEM, SIZE 8 receive FDA 510(k) clearance?

REVELATION POROUS COATED HIP STEM, SIZE 8 received FDA 510(k) clearance on 2012-11-02, under 510(k) number K122636.

Who is the listed applicant for REVELATION POROUS COATED HIP STEM, SIZE 8?

The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REVELATION POROUS COATED HIP STEM, SIZE 8?

The FDA product code for REVELATION POROUS COATED HIP STEM, SIZE 8 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.