FDA 510(k)

36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)

K-Number: K021310 · 2002-05-21

Decision Date2002-05-21

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2002-05-21 under 510(k) number K021310. 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 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)?

36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) is a medical device that received FDA 510(k) clearance on 2002-05-21. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K021310.

When did 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) receive FDA 510(k) clearance?

36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) received FDA 510(k) clearance on 2002-05-21, under 510(k) number K021310.

Who is the listed applicant for 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)?

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

What is the FDA product code for 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)?

The FDA product code for 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) is JDI.

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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.