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FDA 510(k)

PRO-TOE VO HAMMERTOW IMPLANT SYSTEM

K-Number: K101165 · 2010-07-23

ApplicantWrightmedicaltechnologyinc
Decision Date2010-07-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRO-TOE VO HAMMERTOW IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2010-07-23 under 510(k) number K101165. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-TOE VO HAMMERTOW IMPLANT SYSTEM?

PRO-TOE VO HAMMERTOW IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2010-07-23. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K101165.

When did PRO-TOE VO HAMMERTOW IMPLANT SYSTEM receive FDA 510(k) clearance?

PRO-TOE VO HAMMERTOW IMPLANT SYSTEM received FDA 510(k) clearance on 2010-07-23, under 510(k) number K101165.

Who is the listed applicant for PRO-TOE VO HAMMERTOW IMPLANT SYSTEM?

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

What is the FDA product code for PRO-TOE VO HAMMERTOW IMPLANT SYSTEM?

The FDA product code for PRO-TOE VO HAMMERTOW IMPLANT SYSTEM is HWC. This falls under the Cardiovascular category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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