FDA 510(k)

INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL

K-Number: K122798 · 2012-10-11

Decision Date2012-10-11

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2012-10-11 under 510(k) number K122798. 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 INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL?

INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL is a medical device that received FDA 510(k) clearance on 2012-10-11. The listed applicant is Exactech, Inc.. The 510(k) number is K122798.

When did INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL receive FDA 510(k) clearance?

INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL received FDA 510(k) clearance on 2012-10-11, under 510(k) number K122798.

Who is the listed applicant for INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL?

The FDA 510(k) record lists Exactech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL?

The FDA product code for INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL is LPH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.