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FDA 510(k)

SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM

K-Number: K052810 · 2005-12-20

ApplicantScandius Biomedical, Inc.
Decision Date2005-12-20
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCANDIUS TRITIS TIBIAL 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 2005-12-20 under 510(k) number K052810. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM?

SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-12-20. The listed applicant is Scandius Biomedical, Inc.. The 510(k) number is K052810.

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

SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM received FDA 510(k) clearance on 2005-12-20, under 510(k) number K052810.

Who is the listed applicant for SCANDIUS TRITIS TIBIAL 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 TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM?

The FDA product code for SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM is MBI.

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.

K063497MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEMK063499MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEMK060522SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEMK041961SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEMK041749SCANDIUS ACL RECONSTRUCTION SYSTEM

Related Devices (Code: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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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