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FDA 510(k)

BIOSCREW ABSORBABLE INTERFERENCE SREW

K-Number: K973758 · 1998-02-27

ApplicantLinvatec Corp.
Decision Date1998-02-27
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOSCREW ABSORBABLE INTERFERENCE SREW is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1998-02-27 under 510(k) number K973758. 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 BIOSCREW ABSORBABLE INTERFERENCE SREW?

BIOSCREW ABSORBABLE INTERFERENCE SREW is a medical device that received FDA 510(k) clearance on 1998-02-27. The listed applicant is Linvatec Corp.. The 510(k) number is K973758.

When did BIOSCREW ABSORBABLE INTERFERENCE SREW receive FDA 510(k) clearance?

BIOSCREW ABSORBABLE INTERFERENCE SREW received FDA 510(k) clearance on 1998-02-27, under 510(k) number K973758.

Who is the listed applicant for BIOSCREW ABSORBABLE INTERFERENCE SREW?

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 BIOSCREW ABSORBABLE INTERFERENCE SREW?

The FDA product code for BIOSCREW ABSORBABLE INTERFERENCE SREW is HWC. This falls under the Cardiovascular category.

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Other records listing Linvatec Corp. as applicant

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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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