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FDA 510(k)

PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM

K-Number: K961497 · 1996-06-28

ApplicantHowmedica, Inc.
Decision Date1996-06-28
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica, Inc.. It received FDA 510(k) clearance on 1996-06-28 under 510(k) number K961497. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM?

PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1996-06-28. The listed applicant is Howmedica, Inc.. The 510(k) number is K961497.

When did PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM receive FDA 510(k) clearance?

PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM received FDA 510(k) clearance on 1996-06-28, under 510(k) number K961497.

Who is the listed applicant for PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM?

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

What is the FDA product code for PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM?

The FDA product code for PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM is HRS.

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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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