Medical Device Manufacturer · US , Dallas , TX

Accel Spine - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2012

Recent clearances: PICASSO II MIS SPINAL SYSTEM, CEZANNE II INTERBODY FUSION SYSTEM, SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

View 10 510(k) Devices ↓
10
Total
10
Cleared
0
Denied

FDA 510(k) Regulatory Record - Accel Spine Orthopedic ✕

10 devices
1-10 of 10
Cleared Apr 14, 2014
PICASSO II MIS SPINAL SYSTEM
K140219 · NKB
Orthopedic · 75d
Cleared Oct 09, 2013
CEZANNE II INTERBODY FUSION SYSTEM
K131981 · MAX
Orthopedic · 103d
Cleared Sep 03, 2013
SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
K132366 · KWQ
Orthopedic · 35d
Cleared Aug 20, 2013
SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION
K132365 · MNI
Orthopedic · 21d
Cleared Sep 26, 2012
ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K121567 · MAX
Orthopedic · 120d
Cleared Sep 21, 2012
DALI SPINAL FIXATION SYSTEM
K121568 · NKB
Orthopedic · 115d
Cleared Sep 13, 2012
VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM
K121078 · KWQ
Orthopedic · 157d
Cleared Aug 09, 2012
PICASSO MIS SPINAL FIXATION SYSTEM
K120714 · NKB
Orthopedic · 154d
Cleared Aug 09, 2012
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
K121136 · KWP
Orthopedic · 118d
Cleared Jul 27, 2012
MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM
K121569 · ODP
Orthopedic · 59d
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