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FDA 510(k)

MERETEC CS, CORTICAL SCREWS

K-Number: K130400 · 2013-04-05

ApplicantMerete Medical GmbH
Decision Date2013-04-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MERETEC CS, CORTICAL SCREWS 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 2013-04-05 under 510(k) number K130400. 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 MERETEC CS, CORTICAL SCREWS?

MERETEC CS, CORTICAL SCREWS is a medical device that received FDA 510(k) clearance on 2013-04-05. The listed applicant is Merete Medical GmbH. The 510(k) number is K130400.

When did MERETEC CS, CORTICAL SCREWS receive FDA 510(k) clearance?

MERETEC CS, CORTICAL SCREWS received FDA 510(k) clearance on 2013-04-05, under 510(k) number K130400.

Who is the listed applicant for MERETEC CS, CORTICAL SCREWS?

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 MERETEC CS, CORTICAL SCREWS?

The FDA product code for MERETEC CS, CORTICAL SCREWS 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.

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