FDA 510(k)

MODIFICATION TO TRIDENT ALL POLY CUP

K-Number: K010310 · 2001-03-20

Decision Date2001-03-20

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO TRIDENT ALL POLY CUP 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 2001-03-20 under 510(k) number K010310. 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 MODIFICATION TO TRIDENT ALL POLY CUP?

MODIFICATION TO TRIDENT ALL POLY CUP is a medical device that received FDA 510(k) clearance on 2001-03-20. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K010310.

When did MODIFICATION TO TRIDENT ALL POLY CUP receive FDA 510(k) clearance?

MODIFICATION TO TRIDENT ALL POLY CUP received FDA 510(k) clearance on 2001-03-20, under 510(k) number K010310.

Who is the listed applicant for MODIFICATION TO TRIDENT ALL POLY CUP?

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 MODIFICATION TO TRIDENT ALL POLY CUP?

The FDA product code for MODIFICATION TO TRIDENT ALL POLY CUP 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.