FDA 510(k) Applications Submitted by RANDY LEWIS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160066 |
01/13/2016 |
Pro-Link« Stand-Alone Cervical Spacer System |
Life Spine, Inc. |
| K150126 |
01/20/2015 |
Life Spine Cannulated Screws |
LIFE SPINE INC. |
| K180166 |
01/22/2018 |
Life Spine Lumbar Fixation System (SENTRY) |
Life Spine, Inc. |
| K180215 |
01/25/2018 |
DYNA-LINK ELITE Stand-Alone Anterior Lumbar System |
Life Spine Inc. |
| K160169 |
01/27/2016 |
The Life Spine Subtalar Implant System |
Life Spine |
| K130202 |
01/28/2013 |
IRIS ANTERIOR CERVICAL PLATE |
LIFE SPINE, INC |
| K140236 |
01/30/2014 |
AILERON INTERSPINOUS FIXATION SYSTEM |
LIFE SPINE, INC |
| K150229 |
02/02/2015 |
SOLSTICE OCT System |
LIFE SPINE, INC |
| K150368 |
02/12/2015 |
Tarsa-Link Wedge Fixation System |
Life Spine |
| K150390 |
02/18/2015 |
Nautilus Spinal System |
LIFE SPINE, INC. |
| K140457 |
02/24/2014 |
NAUTILUS SPINAL SYSTEM |
LIFE SPINE, INC |
| K130630 |
03/08/2013 |
PLATEAU SPACER SYSTEM TITANIUM |
LIFE SPINE, INC |
| K180642 |
03/12/2018 |
Pro-Link« Ti Stand-Alone Cervical Spacer System |
Life Spine Inc. |
| K170804 |
03/17/2017 |
The Solstice OCT System |
Life Spine Inc. |
| K180749 |
03/22/2018 |
Life Spine SIMPACT Sacroiliac Joint Fixation System |
Life Spine Inc. |
| K170919 |
03/29/2017 |
The TiBow Expandable Spacer System |
Life Spine Inc. |
| K120998 |
04/02/2012 |
SOLSTICE CROSS CONNECTOR |
LIFE SPINE |
| K121116 |
04/12/2012 |
PLATEAU SPACER SYSTEM |
LIFE SPINE |
| K161037 |
04/13/2016 |
Tarsa-Link Stand-Alone Wedge Fixation System |
LIFE SPINE INC. |
| K121151 |
04/16/2012 |
PRO-LINK CERVICAL SPACER SYSTEM |
LIFE SPINE, INC |
| K131077 |
04/17/2013 |
LIFE SPINE PLATEAU SPACER SYSTEM |
LIFE SPINE |
| K161127 |
04/21/2016 |
The Small PLATEAU (PLATEAU-C) Spacer System |
LIFE SPINE INC. |
| K151196 |
05/05/2015 |
Nautilus Spinal System |
LIFE SPINE, INC |
| K161279 |
05/06/2016 |
Life Spine Metatarsal Hemi Implant |
LIFE SPINE INC. |
| K141222 |
05/12/2014 |
NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM |
LIFE SPINE, INC |
| K141246 |
05/14/2014 |
LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM |
LIFE SPINE, INC |
| K171448 |
05/17/2017 |
Hammertoe Correction System |
Life Spine Inc. |
| K111569 |
06/06/2011 |
PLATEAU SPACER SYSTEM |
LIFE SPINE |
| K111729 |
06/20/2011 |
PILOT SPINAL SYSTEM |
LIFE SPINE, INC |
| K111835 |
06/29/2011 |
PLATEAU SPACER SYSTEM |
LIFE SPINE, INC |
| K111953 |
07/11/2011 |
NAUTILUS SPINAL SYSTEM |
LIFE SPINE |
| K172105 |
07/12/2017 |
The Plateau-LO Spacer System |
Life Spine Inc. |
| K172131 |
07/14/2017 |
2 Hole Lateral Plating System |
Life Spine Inc. |
| K141905 |
07/15/2014 |
PRO-LINK WEDGE SYSTEM |
LIFE SPINE |
| K162266 |
08/11/2016 |
The Cranial Fusion System |
LIFE SPINE INC. |
| K152282 |
08/12/2015 |
Cam Lock Plating System |
LIFE SPINE, INC |
| K142253 |
08/14/2014 |
SOLSTICE OCT System |
LIFE SPINE, INC |
| K132589 |
08/19/2013 |
ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO) |
LIFE SPINE, INC |
| K132760 |
09/04/2013 |
NAUTILUS SPINAL SYSTEM |
LIFE SPINE, INC |
| K132866 |
09/13/2013 |
NAUTILUS SPINAL SYSTEM |
LIFE SPINE, INC |
| K162685 |
09/26/2016 |
2-Piece Hammertoe Correction System |
Life Spine, Inc. |
| K172973 |
09/26/2017 |
Life Spine Foot and Ankle Plating System |
Life Spine Inc. |
| K173047 |
09/28/2017 |
The Solstice OCT System |
Life Spine, Inc. |
| K173182 |
09/29/2017 |
ProLift« Expandable System |
Life Spine Inc. |
| K173286 |
10/16/2017 |
Cannulated Screw Internal Fixation System |
Life Spine Inc. |
| K153065 |
10/22/2015 |
The Hammertoe Correction System |
LIFE SPINE, INC |
| K113157 |
10/26/2011 |
AILERON INTERSPINOUS FIXATION SYSTEM |
LIFE SPINE |
| K123373 |
11/01/2012 |
NAUTILUS SPINAL SYSTEM |
LIFE SPINE |
| K143249 |
11/12/2014 |
SOLSTICE OCT System |
LIFE SPINE, INC |
| K133564 |
11/20/2013 |
MODIFICATION TO NAUTILUS SPINAL SYSTEM |
LIFE SPINE, LLC. |
| K103423 |
11/22/2010 |
MIS ANTERIOR CERVICAL PLATING SYSTEM |
LIFE SPINE |
| K153400 |
11/24/2015 |
ProLift Expandable System |
LIFE SPINE, INC. |
| K133717 |
12/05/2013 |
LONGBOW SPACER SYSTEM |
LIFE SPINE |
| K173883 |
12/21/2017 |
External Fixation System |
Life Spine Inc. |
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