The Life Spine Subtalar Implant System
K-Number: K160169 · 2016-06-23
ApplicantLife Spine
Decision Date2016-06-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
The Life Spine Subtalar Implant System is a medical device manufactured by Life Spine. It received FDA 510(k) clearance on 2016-06-23 under approval number K160169. 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 Life Spine Subtalar Implant System?
The Life Spine Subtalar Implant System is a medical device that received FDA 510(k) clearance on 2016-06-23. It is manufactured by Life Spine. The 510(k) number is K160169.
When was The Life Spine Subtalar Implant System approved by the FDA?
The Life Spine Subtalar Implant System received FDA 510(k) clearance on 2016-06-23, under approval number K160169.
What company makes The Life Spine Subtalar Implant System?
The Life Spine Subtalar Implant System is manufactured by Life Spine.
What is the FDA product code for The Life Spine Subtalar Implant System?
The FDA product code for The Life Spine Subtalar Implant 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.