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FDA 510(k)

MATRYX INTERFERENCE SCREW (5.0-6.5MM)

K-Number: K102410 · 2010-12-21

Decision Date2010-12-21
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MATRYX INTERFERENCE SCREW (5.0-6.5MM) is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Linvatec. It received FDA 510(k) clearance on 2010-12-21 under 510(k) number K102410. 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 (5.0-6.5MM)?

MATRYX INTERFERENCE SCREW (5.0-6.5MM) is a medical device that received FDA 510(k) clearance on 2010-12-21. The listed applicant is Conmed Linvatec. The 510(k) number is K102410.

When did MATRYX INTERFERENCE SCREW (5.0-6.5MM) receive FDA 510(k) clearance?

MATRYX INTERFERENCE SCREW (5.0-6.5MM) received FDA 510(k) clearance on 2010-12-21, under 510(k) number K102410.

Who is the listed applicant for MATRYX INTERFERENCE SCREW (5.0-6.5MM)?

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

What is the FDA product code for MATRYX INTERFERENCE SCREW (5.0-6.5MM)?

The FDA product code for MATRYX INTERFERENCE SCREW (5.0-6.5MM) is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Conmed Linvatec as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 21 devices →

Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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