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FDA 510(k)

MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5

K-Number: K063588 · 2007-03-02

ApplicantConmed Linvatec Biomaterials
Decision Date2007-03-02
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Linvatec Biomaterials. It received FDA 510(k) clearance on 2007-03-02 under 510(k) number K063588. 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, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5?

MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 is a medical device that received FDA 510(k) clearance on 2007-03-02. The listed applicant is Conmed Linvatec Biomaterials. The 510(k) number is K063588.

When did MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 receive FDA 510(k) clearance?

MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 received FDA 510(k) clearance on 2007-03-02, under 510(k) number K063588.

Who is the listed applicant for MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5?

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

What is the FDA product code for MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5?

The FDA product code for MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 is HWC. This falls under the Cardiovascular category.

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Official Source

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