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FDA 510(k)

MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM

K-Number: K063497 · 2006-12-19

ApplicantScandius Biomedical, Inc.
Decision Date2006-12-19
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL 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 2006-12-19 under 510(k) number K063497. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM?

MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-19. The listed applicant is Scandius Biomedical, Inc.. The 510(k) number is K063497.

When did MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM received FDA 510(k) clearance on 2006-12-19, under 510(k) number K063497.

Who is the listed applicant for MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL 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 MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM?

The FDA product code for MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM is MAI.

Related Clinical Trials

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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.

K063499MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEMK060522SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEMK052810SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEMK041961SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEMK041749SCANDIUS ACL RECONSTRUCTION SYSTEM

Related Devices (Code: MAI)

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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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