FDA 510(k)

TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019

K-Number: K130099 · 2013-06-21

Decision Date2013-06-21

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 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 2013-06-21 under 510(k) number K130099. 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 TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019?

TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 is a medical device that received FDA 510(k) clearance on 2013-06-21. The listed applicant is Encore Medical L.P.. The 510(k) number is K130099.

When did TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 receive FDA 510(k) clearance?

TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 received FDA 510(k) clearance on 2013-06-21, under 510(k) number K130099.

Who is the listed applicant for TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019?

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 TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019?

The FDA product code for TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 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.