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FDA 510(k)

ACE AIM TTC FUSION NAIL

K-Number: K003797 · 2000-12-15

ApplicantDePuy Orthopaedics, Inc.
Decision Date2000-12-15
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACE AIM TTC FUSION NAIL is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2000-12-15 under 510(k) number K003797. 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 ACE AIM TTC FUSION NAIL?

ACE AIM TTC FUSION NAIL is a medical device that received FDA 510(k) clearance on 2000-12-15. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K003797.

When did ACE AIM TTC FUSION NAIL receive FDA 510(k) clearance?

ACE AIM TTC FUSION NAIL received FDA 510(k) clearance on 2000-12-15, under 510(k) number K003797.

Who is the listed applicant for ACE AIM TTC FUSION NAIL?

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

What is the FDA product code for ACE AIM TTC FUSION NAIL?

The FDA product code for ACE AIM TTC FUSION 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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