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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Merete Medical GmbH. It received FDA 510(k) clearance on 2016-04-29 under 510(k) 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. The listed applicant is Merete Medical GmbH. The 510(k) number is K160548.

When did MC-Subtalar(TM) II receive FDA 510(k) clearance?

MC-Subtalar(TM) II received FDA 510(k) clearance on 2016-04-29, under 510(k) number K160548.

Who is the listed applicant for MC-Subtalar(TM) II?

The FDA 510(k) record lists Merete Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Merete Medical GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws

Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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