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FDA 510(k)

BIORC ANCHOR

K-Number: K990770 · 1999-07-30

ApplicantLinvatec Corp.
Decision Date1999-07-30
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIORC ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K990770. 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 BIORC ANCHOR?

BIORC ANCHOR is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Linvatec Corp.. The 510(k) number is K990770.

When did BIORC ANCHOR receive FDA 510(k) clearance?

BIORC ANCHOR received FDA 510(k) clearance on 1999-07-30, under 510(k) number K990770.

Who is the listed applicant for BIORC ANCHOR?

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 BIORC ANCHOR?

The FDA product code for BIORC ANCHOR is HWC. This falls under the Cardiovascular category.

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Other records listing Linvatec Corp. as applicant

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Related Devices (Code: HWC)

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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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