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FDA 510(k)

MERETE TWISTCUT SNAP-OFF BONE SCREW

K-Number: K051323 · 2005-07-07

ApplicantMerete Medical GmbH
Decision Date2005-07-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MERETE TWISTCUT SNAP-OFF BONE SCREW 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 2005-07-07 under 510(k) number K051323. 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 TWISTCUT SNAP-OFF BONE SCREW?

MERETE TWISTCUT SNAP-OFF BONE SCREW is a medical device that received FDA 510(k) clearance on 2005-07-07. The listed applicant is Merete Medical GmbH. The 510(k) number is K051323.

When did MERETE TWISTCUT SNAP-OFF BONE SCREW receive FDA 510(k) clearance?

MERETE TWISTCUT SNAP-OFF BONE SCREW received FDA 510(k) clearance on 2005-07-07, under 510(k) number K051323.

Who is the listed applicant for MERETE TWISTCUT SNAP-OFF BONE SCREW?

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 TWISTCUT SNAP-OFF BONE SCREW?

The FDA product code for MERETE TWISTCUT SNAP-OFF BONE SCREW 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

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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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