MC-Subtalar(TM) II
K-Number: K160548 · 2016-04-29
ApplicantMerete Medical GmbH
Decision Date2016-04-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MC-Subtalar(TM) II is a medical device manufactured by Merete Medical GmbH. It received FDA 510(k) clearance on 2016-04-29 under approval number K160548. 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 MC-Subtalar(TM) II?
MC-Subtalar(TM) II is a medical device that received FDA 510(k) clearance on 2016-04-29. It is manufactured by Merete Medical GmbH. The 510(k) number is K160548.
When was MC-Subtalar(TM) II approved by the FDA?
MC-Subtalar(TM) II received FDA 510(k) clearance on 2016-04-29, under approval number K160548.
What company makes MC-Subtalar(TM) II?
MC-Subtalar(TM) II is manufactured by Merete Medical GmbH.
What is the FDA product code for MC-Subtalar(TM) II?
The FDA product code for MC-Subtalar(TM) II is HWC. This falls under the Cardiovascular category.
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Official Source
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