2-Piece Hammertoe Correction System
K-Number: K162685 · 2017-06-09
ApplicantLife Spine, Inc.
Decision Date2017-06-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
2-Piece Hammertoe Correction System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2017-06-09 under approval number K162685. 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 2-Piece Hammertoe Correction System?
2-Piece Hammertoe Correction System is a medical device that received FDA 510(k) clearance on 2017-06-09. It is manufactured by Life Spine, Inc.. The 510(k) number is K162685.
When was 2-Piece Hammertoe Correction System approved by the FDA?
2-Piece Hammertoe Correction System received FDA 510(k) clearance on 2017-06-09, under approval number K162685.
What company makes 2-Piece Hammertoe Correction System?
2-Piece Hammertoe Correction System is manufactured by Life Spine, Inc..
What is the FDA product code for 2-Piece Hammertoe Correction System?
The FDA product code for 2-Piece 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.