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FDA 510(k)

MERETE COMPRESSION SCREWS

K-Number: K091798 · 2009-09-02

ApplicantMerete Medical GmbH
Decision Date2009-09-02
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MERETE COMPRESSION 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 2009-09-02 under 510(k) number K091798. 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 MERETE COMPRESSION SCREWS?

MERETE COMPRESSION SCREWS is a medical device that received FDA 510(k) clearance on 2009-09-02. The listed applicant is Merete Medical GmbH. The 510(k) number is K091798.

When did MERETE COMPRESSION SCREWS receive FDA 510(k) clearance?

MERETE COMPRESSION SCREWS received FDA 510(k) clearance on 2009-09-02, under 510(k) number K091798.

Who is the listed applicant for MERETE COMPRESSION 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 MERETE COMPRESSION SCREWS?

The FDA product code for MERETE COMPRESSION SCREWS is HWC. This falls under the Cardiovascular category.

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Other records listing Merete Medical GmbH as applicant

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Related Devices (Code: HWC)

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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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