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FDA 510(k)

ENCORE SHOULDER REVISION GLENOID

K-Number: K081448 · 2008-09-30

ApplicantEncore Medical L.P.
Decision Date2008-09-30
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENCORE SHOULDER REVISION GLENOID 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 2008-09-30 under 510(k) number K081448. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENCORE SHOULDER REVISION GLENOID?

ENCORE SHOULDER REVISION GLENOID is a medical device that received FDA 510(k) clearance on 2008-09-30. The listed applicant is Encore Medical L.P.. The 510(k) number is K081448.

When did ENCORE SHOULDER REVISION GLENOID receive FDA 510(k) clearance?

ENCORE SHOULDER REVISION GLENOID received FDA 510(k) clearance on 2008-09-30, under 510(k) number K081448.

Who is the listed applicant for ENCORE SHOULDER REVISION GLENOID?

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 SHOULDER REVISION GLENOID?

The FDA product code for ENCORE SHOULDER REVISION GLENOID is MBF.

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Related Devices (Code: MBF)

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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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