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FDA 510(k)

THE CORIFIX LIGAMENT ANCHOR

K-Number: K973005 · 1997-11-10

ApplicantCorin USA
Decision Date1997-11-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THE CORIFIX LIGAMENT ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 1997-11-10 under 510(k) number K973005. 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 THE CORIFIX LIGAMENT ANCHOR?

THE CORIFIX LIGAMENT ANCHOR is a medical device that received FDA 510(k) clearance on 1997-11-10. The listed applicant is Corin USA. The 510(k) number is K973005.

When did THE CORIFIX LIGAMENT ANCHOR receive FDA 510(k) clearance?

THE CORIFIX LIGAMENT ANCHOR received FDA 510(k) clearance on 1997-11-10, under 510(k) number K973005.

Who is the listed applicant for THE CORIFIX LIGAMENT ANCHOR?

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

What is the FDA product code for THE CORIFIX LIGAMENT ANCHOR?

The FDA product code for THE CORIFIX LIGAMENT ANCHOR 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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