Spinal USA - FDA 510(k) Cleared Devices
Recent clearances: VAULT-C INTERVERTEBRAL BODY FUSION DEVICE, FACET SCREW SYSTEM, REFORM PEDICLE SCREW SYSTEM
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spinal USA Orthopedic ✕
23 devices
Cleared
Nov 25, 2013
VAULT-C INTERVERTEBRAL BODY FUSION DEVICE
Orthopedic
147d
Cleared
Aug 09, 2013
FACET SCREW SYSTEM
Orthopedic
134d
Cleared
Jul 24, 2013
REFORM PEDICLE SCREW SYSTEM
Orthopedic
76d
Cleared
Jun 20, 2013
REFORM PEDICLE SCREW SYSTEM
Orthopedic
135d
Cleared
Apr 25, 2013
VAULT ALIF SYSTEM
Orthopedic
63d
Cleared
Nov 20, 2012
S-LOK PSS SYSTEM
Orthopedic
57d
Cleared
Aug 08, 2012
REFORM PEDICLE SCREW SYSTEM
Orthopedic
113d
Cleared
Sep 15, 2011
SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM
Orthopedic
62d
Cleared
Apr 04, 2011
VAULT ALIF SYSTEM
Orthopedic
138d
Cleared
Nov 17, 2009
SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25
Orthopedic
81d
Cleared
Sep 25, 2009
SPINAL USA INTERBODY CAGES
Orthopedic
66d
Cleared
Sep 14, 2009
MODIFICATION TO: PSS SYSTEM
Orthopedic
61d