Medical Device Manufacturer · US , Brandon , MS

Spinal USA - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 2006
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spinal USA Orthopedic ✕
23 devices
1-12 of 23
Cleared Nov 25, 2013
VAULT-C INTERVERTEBRAL BODY FUSION DEVICE
K132029 · OVE
Orthopedic · 147d
Cleared Aug 09, 2013
FACET SCREW SYSTEM
K130863 · MRW
Orthopedic · 134d
Cleared Jul 24, 2013
REFORM PEDICLE SCREW SYSTEM
K131343 · MNI
Orthopedic · 76d
Cleared Jun 20, 2013
REFORM PEDICLE SCREW SYSTEM
K130279 · MNI
Orthopedic · 135d
Cleared Apr 25, 2013
VAULT ALIF SYSTEM
K130445 · OVD
Orthopedic · 63d
Cleared Nov 20, 2012
S-LOK PSS SYSTEM
K122931 · MNI
Orthopedic · 57d
Cleared Aug 08, 2012
REFORM PEDICLE SCREW SYSTEM
K121172 · MNI
Orthopedic · 113d
Cleared Sep 15, 2011
SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM
K112025 · KWP
Orthopedic · 62d
Cleared Apr 04, 2011
VAULT ALIF SYSTEM
K103369 · OVD
Orthopedic · 138d
Cleared Nov 17, 2009
SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25
K092659 · KWQ
Orthopedic · 81d
Cleared Sep 25, 2009
SPINAL USA INTERBODY CAGES
K092193 · MAX
Orthopedic · 66d
Cleared Sep 14, 2009
MODIFICATION TO: PSS SYSTEM
K092128 · MNI
Orthopedic · 61d
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