Medical Device Manufacturer · US , Littleton , MA

Scandius Biomedical, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2004
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Scandius Biomedical, Inc. Orthopedic ✕
6 devices
1-6 of 6
Cleared Dec 19, 2006
MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
K063497 · MAI
Orthopedic · 29d
Cleared Dec 19, 2006
MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
K063499 · MBI
Orthopedic · 29d
Cleared Apr 11, 2006
SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
K060522 · MAI
Orthopedic · 43d
Cleared Dec 20, 2005
SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
K052810 · MBI
Orthopedic · 77d
Cleared Oct 20, 2004
SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM
K041961 · HWC
Orthopedic · 91d
Cleared Sep 08, 2004
SCANDIUS ACL RECONSTRUCTION SYSTEM
K041749 · HWC
Orthopedic · 71d
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