Accel Spine

Dallas, TX, US

Accel Spine appears in FDA device records in Dallas, TX. FDA records list 10 510(k) clearances between 2012-07-27 and 2014-04-14, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 10
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 10 510(k) clearances for Accel Spine between 2012 and 2014. The busiest year on record is 2012, with 6. The most recent is 2014, with 1.

Clearances by year, as a table

510(k) clearance decisions for Accel Spine, by decision year
Year	Clearances
2012	6
2013	3
2014	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K140219	PICASSO II MIS SPINAL SYSTEM	NKB	Substantially Equivalent	2014-04-14
K131981	CEZANNE II INTERBODY FUSION SYSTEM	MAX	Substantially Equivalent	2013-10-09
K132366	SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS	KWQ	Substantially Equivalent	2013-09-03
K132365	SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION	MNI	Substantially Equivalent	2013-08-20
K121567	ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM	MAX	Substantially Equivalent	2012-09-26
K121568	DALI SPINAL FIXATION SYSTEM	NKB	Substantially Equivalent	2012-09-21
K121078	VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM	KWQ	Substantially Equivalent	2012-09-13
K121136	RENOIR POSTERIOR CERVIAL FIXATION SYSTEM	KWP	Substantially Equivalent	2012-08-09
K120714	PICASSO MIS SPINAL FIXATION SYSTEM	NKB	Substantially Equivalent	2012-08-09
K121569	MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM	ODP	Substantially Equivalent	2012-07-27

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain