Atlas FDA

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

Spine View, Inc. — Predicate Candidate Screening

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

115 daysmedian FDA review time
196 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K160856SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.2016-08-011260
K152539SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.2016-02-241730
K122134FLEXLITE CAMERASpine View, Inc.2012-12-271620
K121548SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)Spine View, Inc.2012-08-16830
K120680ENSPIRE DISCECTOMY SYSTEMSpine View, Inc.2012-06-261120
K113362SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)Spine View, Inc.2012-02-10870
K110992ENSPIRE DEBRIDER SYSTEMSpine View, Inc.2011-10-211960
K090278ENSPIRE DEBRIDER SYSTEMSpine View, Inc.2009-04-15700
K081051SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPESpine View, Inc.2008-08-071150

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