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FDA 510(k)

DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL

K-Number: K972183 · 1997-08-26

ApplicantAce Medical Co.
Decision Date1997-08-26
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Ace Medical Co.. It received FDA 510(k) clearance on 1997-08-26 under 510(k) number K972183. 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 A.I.M. TITANIUM TIBIAL NAIL?

DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL is a medical device that received FDA 510(k) clearance on 1997-08-26. The listed applicant is Ace Medical Co.. The 510(k) number is K972183.

When did DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL receive FDA 510(k) clearance?

DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL received FDA 510(k) clearance on 1997-08-26, under 510(k) number K972183.

Who is the listed applicant for DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL?

The FDA 510(k) record lists Ace Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL?

The FDA product code for DEPUY ACE A.I.M. TITANIUM TIBIAL 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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