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FDA 510(k)

EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER

K-Number: K020291 · 2002-02-27

ApplicantExactech, Inc.
Decision Date2002-02-27
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2002-02-27 under 510(k) number K020291. 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 EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER?

EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER is a medical device that received FDA 510(k) clearance on 2002-02-27. The listed applicant is Exactech, Inc.. The 510(k) number is K020291.

When did EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER receive FDA 510(k) clearance?

EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER received FDA 510(k) clearance on 2002-02-27, under 510(k) number K020291.

Who is the listed applicant for EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER?

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 EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER?

The FDA product code for EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER is JDI.

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Related Devices (Code: JDI)

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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