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FDA 510(k)

ENCORE KNEE SYSTEM IFU

K-Number: K063406 · 2007-01-08

ApplicantEncore Medical L.P.
Decision Date2007-01-08
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENCORE KNEE SYSTEM IFU 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 2007-01-08 under 510(k) number K063406. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENCORE KNEE SYSTEM IFU?

ENCORE KNEE SYSTEM IFU is a medical device that received FDA 510(k) clearance on 2007-01-08. The listed applicant is Encore Medical L.P.. The 510(k) number is K063406.

When did ENCORE KNEE SYSTEM IFU receive FDA 510(k) clearance?

ENCORE KNEE SYSTEM IFU received FDA 510(k) clearance on 2007-01-08, under 510(k) number K063406.

Who is the listed applicant for ENCORE KNEE SYSTEM IFU?

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 KNEE SYSTEM IFU?

The FDA product code for ENCORE KNEE SYSTEM IFU is JWH.

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Related Devices (Code: JWH)

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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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