FDA 510(k)

FOUNDATION POROUS COATED HEMISPHERICAL SHELL

K-Number: K974093 · 1998-01-28

Decision Date1998-01-28

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FOUNDATION POROUS COATED HEMISPHERICAL SHELL is the device name listed in this FDA 510(k) record. The listed applicant is Encore Orthopedics, Inc.. It received FDA 510(k) clearance on 1998-01-28 under 510(k) number K974093. 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 FOUNDATION POROUS COATED HEMISPHERICAL SHELL?

FOUNDATION POROUS COATED HEMISPHERICAL SHELL is a medical device that received FDA 510(k) clearance on 1998-01-28. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K974093.

When did FOUNDATION POROUS COATED HEMISPHERICAL SHELL receive FDA 510(k) clearance?

FOUNDATION POROUS COATED HEMISPHERICAL SHELL received FDA 510(k) clearance on 1998-01-28, under 510(k) number K974093.

Who is the listed applicant for FOUNDATION POROUS COATED HEMISPHERICAL SHELL?

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

What is the FDA product code for FOUNDATION POROUS COATED HEMISPHERICAL SHELL?

The FDA product code for FOUNDATION POROUS COATED HEMISPHERICAL 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.