Scandius Biomedical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM, MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM, SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Scandius Biomedical, Inc. Orthopedic ✕
6 devices
Cleared
Dec 19, 2006
MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
Orthopedic
29d
Cleared
Dec 19, 2006
MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
Orthopedic
29d
Cleared
Apr 11, 2006
SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
Orthopedic
43d
Cleared
Dec 20, 2005
SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
Orthopedic
77d
Cleared
Oct 20, 2004
SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM
Orthopedic
91d
Cleared
Sep 08, 2004
SCANDIUS ACL RECONSTRUCTION SYSTEM
Orthopedic
71d