Atlas FDA

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

Spine Vision, Inc. — Predicate Candidate Screening

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

84 daysmedian FDA review time
133 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K052406UNI-THREAD SPINAL SYSTEMSpine Vision, Inc.2005-11-07670
K030526PEDIGUARD NERVE DETECTOR SYSTEMSpine Vision, Inc.2004-12-296790
K042930SPACEVISION CAGE SYSTEMSpine Vision, Inc.2004-12-28670
K042640UNI-THREAD SPINAL SYSTEMSpine Vision, Inc.2004-11-23570
K033508PLUS PIVOT LINK UNIVERSAL SYSTEMSpine Vision, Inc.2004-01-27820
K032398PLUS PIVOT LINK UNIVERSAL SYSTEMSpine Vision, Inc.2003-10-31880
K022271PLUS PIVOT LINK UNIVERSAL SYSTEMSpine Vision, Inc.2002-09-23720
K021507PLUS PIVOT LINK UNIVERSAL SYSTEMSpine Vision, Inc.2002-08-01840
K021510UNI-T UNI-THREAD SPINAL SYSTEMSpine Vision, Inc.2002-08-01840
K013301UNI-T SPINAL SYSTEMSpine Vision, Inc.2002-02-131330
K013312P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)Spine Vision, Inc.2002-02-131320
K012881C3 ANTERIOR CERVICAL PLATE SYSTEMSpine Vision, Inc.2001-11-26900

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