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 a medical device manufactured by Arthrosurface, Inc.. It received FDA 510(k) clearance on 2017-03-03 under approval 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. It is manufactured by Arthrosurface, Inc.. The 510(k) number is K170350.
When was ToeMATE® Hammertoe Correction System approved by the FDA?
ToeMATE® Hammertoe Correction System received FDA 510(k) clearance on 2017-03-03, under approval number K170350.
What company makes ToeMATE® Hammertoe Correction System?
ToeMATE® Hammertoe Correction System is manufactured by Arthrosurface, Inc..
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.
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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.