The Hammertoe Correction System
K-Number: K153065 · 2016-08-01
ApplicantLife Spine, Inc.
Decision Date2016-08-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
The Hammertoe Correction System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2016-08-01 under approval number K153065. 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 The Hammertoe Correction System?
The Hammertoe Correction System is a medical device that received FDA 510(k) clearance on 2016-08-01. It is manufactured by Life Spine, Inc.. The 510(k) number is K153065.
When was The Hammertoe Correction System approved by the FDA?
The Hammertoe Correction System received FDA 510(k) clearance on 2016-08-01, under approval number K153065.
What company makes The Hammertoe Correction System?
The Hammertoe Correction System is manufactured by Life Spine, Inc..
What is the FDA product code for The Hammertoe Correction System?
The FDA product code for The Hammertoe Correction System is HWC. This falls under the Cardiovascular category.
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Official Source
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