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FDA 510(k)

SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM

K-Number: K041961 · 2004-10-20

ApplicantScandius Biomedical, Inc.
Decision Date2004-10-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Scandius Biomedical, Inc.. It received FDA 510(k) clearance on 2004-10-20 under 510(k) number K041961. 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 SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM?

SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-20. The listed applicant is Scandius Biomedical, Inc.. The 510(k) number is K041961.

When did SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM receive FDA 510(k) clearance?

SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM received FDA 510(k) clearance on 2004-10-20, under 510(k) number K041961.

Who is the listed applicant for SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM?

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

What is the FDA product code for SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM?

The FDA product code for SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Scandius Biomedical, 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.

K063497MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEMK063499MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEMK060522SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEMK052810SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEMK041749SCANDIUS ACL RECONSTRUCTION SYSTEM

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Official Source

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