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

Accel Spine — Predicate Candidate Screening

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

115 daysmedian FDA review time

157 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K140219	PICASSO II MIS SPINAL SYSTEM	Accel Spine	2014-04-14	75	0
K131981	CEZANNE II INTERBODY FUSION SYSTEM	Accel Spine	2013-10-09	103	0
K132366	SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS	Accel Spine	2013-09-03	35	0
K132365	SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION	Accel Spine	2013-08-20	21	2
K121567	ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM	Accel Spine	2012-09-26	120	0
K121568	DALI SPINAL FIXATION SYSTEM	Accel Spine	2012-09-21	115	0
K121078	VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM	Accel Spine	2012-09-13	157	0
K121136	RENOIR POSTERIOR CERVIAL FIXATION SYSTEM	Accel Spine	2012-08-09	118	0
K120714	PICASSO MIS SPINAL FIXATION SYSTEM	Accel Spine	2012-08-09	154	0
K121569	MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM	Accel Spine	2012-07-27	59	0

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