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FDA 510(k)

NOVATION 12/14 PRESS-FIT FEMORAL STEM

K-Number: K042842 · 2004-11-09

ApplicantExactech, Inc.
Decision Date2004-11-09
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NOVATION 12/14 PRESS-FIT FEMORAL STEM is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2004-11-09 under 510(k) number K042842. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVATION 12/14 PRESS-FIT FEMORAL STEM?

NOVATION 12/14 PRESS-FIT FEMORAL STEM is a medical device that received FDA 510(k) clearance on 2004-11-09. The listed applicant is Exactech, Inc.. The 510(k) number is K042842.

When did NOVATION 12/14 PRESS-FIT FEMORAL STEM receive FDA 510(k) clearance?

NOVATION 12/14 PRESS-FIT FEMORAL STEM received FDA 510(k) clearance on 2004-11-09, under 510(k) number K042842.

Who is the listed applicant for NOVATION 12/14 PRESS-FIT FEMORAL STEM?

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 12/14 PRESS-FIT FEMORAL STEM?

The FDA product code for NOVATION 12/14 PRESS-FIT FEMORAL STEM is LZO.

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Related Devices (Code: LZO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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