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FDA 510(k)

DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS

K-Number: K033329 · 2003-11-14

ApplicantDepuy, Inc.
Decision Date2003-11-14
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 2003-11-14 under 510(k) number K033329. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS?

DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS is a medical device that received FDA 510(k) clearance on 2003-11-14. The listed applicant is Depuy, Inc.. The 510(k) number is K033329.

When did DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS receive FDA 510(k) clearance?

DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS received FDA 510(k) clearance on 2003-11-14, under 510(k) number K033329.

Who is the listed applicant for DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS?

The FDA 510(k) record lists Depuy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS?

The FDA product code for DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS is HSB.

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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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