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FDA 510(k)

MENISCAL REPAIR DEVICE

K-Number: K974538 · 1998-03-03

ApplicantLinvatec Corp.
Decision Date1998-03-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MENISCAL REPAIR DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1998-03-03 under 510(k) number K974538. 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 MENISCAL REPAIR DEVICE?

MENISCAL REPAIR DEVICE is a medical device that received FDA 510(k) clearance on 1998-03-03. The listed applicant is Linvatec Corp.. The 510(k) number is K974538.

When did MENISCAL REPAIR DEVICE receive FDA 510(k) clearance?

MENISCAL REPAIR DEVICE received FDA 510(k) clearance on 1998-03-03, under 510(k) number K974538.

Who is the listed applicant for MENISCAL REPAIR DEVICE?

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

What is the FDA product code for MENISCAL REPAIR DEVICE?

The FDA product code for MENISCAL REPAIR DEVICE is HWC. This falls under the Cardiovascular category.

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Other records listing Linvatec Corp. 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.

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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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