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FDA 510(k)

NOVATION CFS PRESS-FIT AND CEMENTED STEMS

K-Number: K090764 · 2009-04-21

ApplicantExactech, Inc.
Decision Date2009-04-21
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NOVATION CFS PRESS-FIT AND CEMENTED STEMS is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2009-04-21 under 510(k) number K090764. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVATION CFS PRESS-FIT AND CEMENTED STEMS?

NOVATION CFS PRESS-FIT AND CEMENTED STEMS is a medical device that received FDA 510(k) clearance on 2009-04-21. The listed applicant is Exactech, Inc.. The 510(k) number is K090764.

When did NOVATION CFS PRESS-FIT AND CEMENTED STEMS receive FDA 510(k) clearance?

NOVATION CFS PRESS-FIT AND CEMENTED STEMS received FDA 510(k) clearance on 2009-04-21, under 510(k) number K090764.

Who is the listed applicant for NOVATION CFS PRESS-FIT AND CEMENTED STEMS?

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 NOVATION CFS PRESS-FIT AND CEMENTED STEMS?

The FDA product code for NOVATION CFS PRESS-FIT AND CEMENTED STEMS is LWJ.

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Related Devices (Code: LWJ)

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K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.K062383UNISYN HA PLASMA MODULAR HIPHayes Medical, Inc.

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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