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

NVR — Predicate Candidate Screening

6 FDA 510(k) clearances under this product code; the 50 most recent screened below.

170 daysmedian FDA review time

322 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K073274	SPINAL SPHERE SYSTEM	Life Spine	2008-03-17	117	0
K073105	PEEK SPINAL SPHERES	Interbody Innovations, Llp	2008-01-03	62	0
K062992	SPINAL SPHERES	Interbody Innovations, Llp	2007-07-27	298	0
K063139	SPINAL STABILIZING SPHERE SYSTEM	Biomet Spine	2007-04-04	170	0
K060415	MODIFICATION TO: SATELLITE SPINAL SYSTEM	Medtronic Sofamor Danek	2007-01-05	322	0
K051320	SATELLITE SPINAL SYSTEM	Medtronic Sofamor Danek	2005-09-09	112	2

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