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Spinal USA

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
24
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K132029VAULT-C INTERVERTEBRAL BODY FUSION DEVICENovember 25, 2013
K130863FACET SCREW SYSTEMAugust 9, 2013
K131343REFORM PEDICLE SCREW SYSTEMJuly 24, 2013
K130279REFORM PEDICLE SCREW SYSTEMJune 20, 2013
K130445VAULT ALIF SYSTEMApril 25, 2013
K122931S-LOK PSS SYSTEMNovember 20, 2012
K121172REFORM PEDICLE SCREW SYSTEMAugust 8, 2012
K112748SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEMJuly 11, 2012
K112025SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEMSeptember 15, 2011
K103369VAULT ALIF SYSTEMApril 4, 2011
K092659SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25November 17, 2009
K092193SPINAL USA INTERBODY CAGESSeptember 25, 2009
K092128MODIFICATION TO: PSS SYSTEMSeptember 14, 2009
K091044SPINAL USA ANTERIOR LUMBAR PLATE SYSTEMJuly 9, 2009
K083118SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICEMay 27, 2009
K090033MODIFICATION TO: PSS SYSTEMMay 6, 2009
K081196SPINAL USA VBR SYSTEMOctober 16, 2008
K080314SPINAL USA INTERBODY FUSION DEVICEMay 13, 2008
K073240PSS SYSTEMMarch 20, 2008
K070922MODIFICATION TO SPINAL USA VBR SYSTEMSeptember 19, 2007