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FDA 510(k)

MODIFICATION TO SMARTPIN

K-Number: K041288 · 2004-06-10

ApplicantLinvatec Biomaterials, Inc.
Decision Date2004-06-10
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SMARTPIN is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Biomaterials, Inc.. It received FDA 510(k) clearance on 2004-06-10 under 510(k) number K041288. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO SMARTPIN?

MODIFICATION TO SMARTPIN is a medical device that received FDA 510(k) clearance on 2004-06-10. The listed applicant is Linvatec Biomaterials, Inc.. The 510(k) number is K041288.

When did MODIFICATION TO SMARTPIN receive FDA 510(k) clearance?

MODIFICATION TO SMARTPIN received FDA 510(k) clearance on 2004-06-10, under 510(k) number K041288.

Who is the listed applicant for MODIFICATION TO SMARTPIN?

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

What is the FDA product code for MODIFICATION TO SMARTPIN?

The FDA product code for MODIFICATION TO SMARTPIN is HTY.

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Official Source

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