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FDA 510(k)

DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL

K-Number: K974781 · 1998-03-10

ApplicantDepuy, Inc.
Decision Date1998-03-10
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1998-03-10 under 510(k) number K974781. 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 AIM(R) TITANIUM SUPRACONDYLAR NAIL?

DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL is a medical device that received FDA 510(k) clearance on 1998-03-10. The listed applicant is Depuy, Inc.. The 510(k) number is K974781.

When did DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL receive FDA 510(k) clearance?

DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL received FDA 510(k) clearance on 1998-03-10, under 510(k) number K974781.

Who is the listed applicant for DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL?

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 AIM(R) TITANIUM SUPRACONDYLAR NAIL?

The FDA product code for DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL 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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