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FDA 510(k)

OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,

K-Number: K032894 · 2004-05-07

ApplicantLinvatec Biomaterials, Inc.
Decision Date2004-05-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Biomaterials, Inc.. It received FDA 510(k) clearance on 2004-05-07 under 510(k) number K032894. 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 OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,?

OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, is a medical device that received FDA 510(k) clearance on 2004-05-07. The listed applicant is Linvatec Biomaterials, Inc.. The 510(k) number is K032894.

When did OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, receive FDA 510(k) clearance?

OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, received FDA 510(k) clearance on 2004-05-07, under 510(k) number K032894.

Who is the listed applicant for OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,?

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

What is the FDA product code for OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,?

The FDA product code for OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, is HWC. This falls under the Cardiovascular category.

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Other records listing Linvatec Biomaterials, Inc. 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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Official Source

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