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FDA 510(k)

PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION

K-Number: K120645 · 2012-04-24

ApplicantWrightmedicaltechnologyinc
Decision Date2012-04-24
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2012-04-24 under 510(k) number K120645. 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(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION?

PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION is a medical device that received FDA 510(k) clearance on 2012-04-24. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K120645.

When did PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION receive FDA 510(k) clearance?

PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION received FDA 510(k) clearance on 2012-04-24, under 510(k) number K120645.

Who is the listed applicant for PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION?

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(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION?

The FDA product code for PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION 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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