Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Spinal USA — Predicate Candidate Screening

23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

97 daysmedian FDA review time

170 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K132029	VAULT-C INTERVERTEBRAL BODY FUSION DEVICE	Spinal USA	2013-11-25	147
K130863	FACET SCREW SYSTEM	Spinal USA	2013-08-09	134
K131343	REFORM PEDICLE SCREW SYSTEM	Spinal USA	2013-07-24	76
K130279	REFORM PEDICLE SCREW SYSTEM	Spinal USA	2013-06-20	135
K130445	VAULT ALIF SYSTEM	Spinal USA	2013-04-25	63
K122931	S-LOK PSS SYSTEM	Spinal USA	2012-11-20	57
K121172	REFORM PEDICLE SCREW SYSTEM	Spinal USA	2012-08-08	113
K112025	SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM	Spinal USA	2011-09-15	62
K103369	VAULT ALIF SYSTEM	Spinal USA	2011-04-04	138
K092659	SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 2	Spinal USA	2009-11-17	81
K092193	SPINAL USA INTERBODY CAGES	Spinal USA	2009-09-25	66
K092128	MODIFICATION TO: PSS SYSTEM	Spinal USA	2009-09-14	61
K091044	SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM	Spinal USA	2009-07-09	87
K083118	SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE	Spinal USA	2009-05-27	217
K090033	MODIFICATION TO: PSS SYSTEM	Spinal USA	2009-05-06	120
K081196	SPINAL USA VBR SYSTEM	Spinal USA	2008-10-16	171
K080314	SPINAL USA INTERBODY FUSION DEVICE	Spinal USA	2008-05-13	97
K073240	PSS SYSTEM	Spinal USA	2008-03-20	125
K070922	MODIFICATION TO SPINAL USA VBR SYSTEM	Spinal USA	2007-09-19	170
K071438	PSS SYSTEM	Spinal USA	2007-08-21	90
K061752	SPINAL USA VBR SYSTEM	Spinal USA	2006-08-15	55
K060025	SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM	Spinal USA	2006-04-18	104
K060132	SPINAL USA CEMENT RESTRICTOR SYSTEM	Spinal USA	2006-03-16	57

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda