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FDA 510(k)

NOVATION LPI PRIME FEMORAL STEM

K-Number: K121684 · 2012-10-01

ApplicantExactech, Inc.
Decision Date2012-10-01
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NOVATION LPI PRIME 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 2012-10-01 under 510(k) number K121684. 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 NOVATION LPI PRIME FEMORAL STEM?

NOVATION LPI PRIME FEMORAL STEM is a medical device that received FDA 510(k) clearance on 2012-10-01. The listed applicant is Exactech, Inc.. The 510(k) number is K121684.

When did NOVATION LPI PRIME FEMORAL STEM receive FDA 510(k) clearance?

NOVATION LPI PRIME FEMORAL STEM received FDA 510(k) clearance on 2012-10-01, under 510(k) number K121684.

Who is the listed applicant for NOVATION LPI PRIME 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 LPI PRIME FEMORAL STEM?

The FDA product code for NOVATION LPI PRIME FEMORAL STEM is LPH.

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Related Devices (Code: LPH)

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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