FDA 510(k)

THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ

K-Number: K992409 · 1999-10-08

Decision Date1999-10-08

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 1999-10-08 under 510(k) number K992409. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ?

THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ is a medical device that received FDA 510(k) clearance on 1999-10-08. The listed applicant is Implex Corp.. The 510(k) number is K992409.

When did THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ receive FDA 510(k) clearance?

THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ received FDA 510(k) clearance on 1999-10-08, under 510(k) number K992409.

Who is the listed applicant for THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ?

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

What is the FDA product code for THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ?

The FDA product code for THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ is JDI.

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Other records listing Implex Corp. as applicant

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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.