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FDA 510(k)

MATRYX INTERFERENCE SCREW

K-Number: K052080 · 2005-08-25

ApplicantLinvatec Biomaterials, Inc.
Decision Date2005-08-25
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MATRYX INTERFERENCE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Biomaterials, Inc.. It received FDA 510(k) clearance on 2005-08-25 under 510(k) number K052080. 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 MATRYX INTERFERENCE SCREW?

MATRYX INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 2005-08-25. The listed applicant is Linvatec Biomaterials, Inc.. The 510(k) number is K052080.

When did MATRYX INTERFERENCE SCREW receive FDA 510(k) clearance?

MATRYX INTERFERENCE SCREW received FDA 510(k) clearance on 2005-08-25, under 510(k) number K052080.

Who is the listed applicant for MATRYX INTERFERENCE SCREW?

The FDA 510(k) record lists Linvatec Biomaterials, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MATRYX INTERFERENCE SCREW?

The FDA product code for MATRYX INTERFERENCE SCREW is HWC. This falls under the Cardiovascular category.

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Official Source

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