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FDA 510(k)

X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER

K-Number: K130365 · 2013-09-23

ApplicantEncore Medical L.P.
Decision Date2013-09-23
Product CodeOQG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER 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 2013-09-23 under 510(k) number K130365. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER?

X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER is a medical device that received FDA 510(k) clearance on 2013-09-23. The listed applicant is Encore Medical L.P.. The 510(k) number is K130365.

When did X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER receive FDA 510(k) clearance?

X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER received FDA 510(k) clearance on 2013-09-23, under 510(k) number K130365.

Who is the listed applicant for X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER?

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 X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER?

The FDA product code for X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER is OQG.

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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.

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