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FDA 510(k)

ToeMATE® Hammertoe Correction System

K-Number: K170350 · 2017-03-03

ApplicantArthrosurface, Inc.
Decision Date2017-03-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ToeMATE® Hammertoe Correction System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2017-03-03 under 510(k) number K170350. 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 ToeMATE® Hammertoe Correction System?

ToeMATE® Hammertoe Correction System is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K170350.

When did ToeMATE® Hammertoe Correction System receive FDA 510(k) clearance?

ToeMATE® Hammertoe Correction System received FDA 510(k) clearance on 2017-03-03, under 510(k) number K170350.

Who is the listed applicant for ToeMATE® Hammertoe Correction System?

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

What is the FDA product code for ToeMATE® Hammertoe Correction System?

The FDA product code for ToeMATE® Hammertoe Correction System is HWC. This falls under the Cardiovascular category.

Other records listing Arthrosurface, Inc. as applicant

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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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