Spinal Elements, Inc. - FDA 510(k) Cleared Devices
48
Total
48
Cleared
0
Denied
48 devices
Cleared
May 19, 2015
Lucent
Orthopedic
126d
Cleared
Dec 10, 2014
Crystal ®
Orthopedic
418d
Cleared
Aug 22, 2014
MERCURY SPINAL SYSTEM
Orthopedic
87d
Cleared
Oct 24, 2013
LOTUS
Orthopedic
160d
Cleared
Feb 21, 2013
LUCENT
Orthopedic
149d
Cleared
Jan 10, 2013
SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
Orthopedic
122d
Cleared
Jul 30, 2012
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM
Orthopedic
166d
Cleared
Jul 03, 2012
SPINAL ELEMENTS CERCLAGE SYSTEM
Orthopedic
165d
Cleared
May 23, 2012
LUCENT OR LUCENT MAGNUM
Orthopedic
446d
Cleared
Oct 14, 2010
SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM
Orthopedic
105d
Cleared
Jul 01, 2009
MERCURY SPINAL SYSTEM
Orthopedic
29d
Cleared
Feb 18, 2009
AXXION LIGHT GUIDE
General & Plastic Surgery
134d
Cleared
Feb 13, 2009
LUCENT MAGNUM
Orthopedic
81d
Cleared
Jan 22, 2009
MERCURY SPINAL SYSTEM
Orthopedic
160d
Cleared
Dec 03, 2008
MERCURY SPINAL SYSTEM
Orthopedic
30d
Cleared
Sep 11, 2008
LUCENT MAGNUM+
Orthopedic
86d
Cleared
Aug 05, 2008
MODIFICATION TO LUCENT
Orthopedic
26d
Cleared
Jul 14, 2008
SPINAL ELEMENTS BUTTRESS PLATE SYSTEM
Orthopedic
55d
Cleared
Jan 24, 2008
CRYSTAL
Orthopedic
56d
Cleared
Dec 26, 2007
LUCENT MAGNUM
Orthopedic
27d
Cleared
Nov 09, 2007
LUCENT
Orthopedic
137d
Cleared
Oct 23, 2007
MOSAIC DEVICES
Orthopedic
112d
Cleared
Oct 12, 2007
MERCURY SPINAL SYSTEM
Orthopedic
93d