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FDA 510(k)

ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS

K-Number: K082398 · 2008-10-15

ApplicantEncore Medical L.P.
Decision Date2008-10-15
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS 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 2008-10-15 under 510(k) number K082398. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS?

ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS is a medical device that received FDA 510(k) clearance on 2008-10-15. The listed applicant is Encore Medical L.P.. The 510(k) number is K082398.

When did ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS receive FDA 510(k) clearance?

ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS received FDA 510(k) clearance on 2008-10-15, under 510(k) number K082398.

Who is the listed applicant for ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS?

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 ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS?

The FDA product code for ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS is LZO.

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Related Devices (Code: LZO)

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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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