FDA 510(k) Applications Submitted by Meredith Lee May
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120091 |
01/11/2012 |
R&D INNOVATION PEDICLE SCREW SYSTEM |
R&D INNOVATION, LLC |
| K140107 |
01/15/2014 |
EMERGE MEDICAL DISTAL RADIUS SET |
EMERGE MEDICAL |
| K130279 |
02/05/2013 |
REFORM PEDICLE SCREW SYSTEM |
SPINAL USA |
| K120515 |
02/21/2012 |
TEMPUS CERVICAL PLATE SYSTEM |
NEUROSTRUCTURES, LLC |
| K121276 |
04/27/2012 |
NEURO VENTION LAMINPLASTY PLATING SYSTEM |
NEUROVENTION LLC |
| K131250 |
05/02/2013 |
TIGER SPINE SYSTEM |
CORELINK LLC |
| K131343 |
05/09/2013 |
REFORM PEDICLE SCREW SYSTEM |
SPINAL USA |
| K131374 |
05/13/2013 |
TEMPUS(TM) CERVICAL PLATE SYSTEM |
NEUROSTRUCTURES, LLC |
| K141282 |
05/16/2014 |
PGS 5.5 MM CANNULATED PEDICLE SCREW |
PINNACLE SPINE GROUP |
| K121551 |
05/25/2012 |
RESOLUTE FACET SCREW SYSTEM |
NEUROSTRUCTURES, LLC |
| K131880 |
06/25/2013 |
SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM |
SPINEFRONTIER, INC. |
| K132029 |
07/01/2013 |
VAULT-C INTERVERTEBRAL BODY FUSION DEVICE |
SPINAL USA |
| K122229 |
07/26/2012 |
VICEROY SPINAL SYSTEM |
TORREY SPINE |
| K142060 |
07/29/2014 |
TRANSOM ANTERIOR CERVICAL PLATE |
NEUROSTRUCTURES, INC. |
| K182346 |
08/28/2018 |
TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws |
Exactech, Inc. |
| K122822 |
09/14/2012 |
SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM |
SPECTRUM SPINE, LLC |
| K133363 |
11/01/2013 |
INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM |
LDR SPINE, USA, INC. |
| K133813 |
12/16/2013 |
FLXFIT INTERVERTEBRAL BODY FUSION DEVICE |
EXPANDING ORTHOPEDICS, INC. |
| K140098 |
01/14/2014 |
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM |
EMERGE MEDICAL |
| K140119 |
01/16/2014 |
EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM |
EMERGE MEDICAL |
| K141129 |
05/01/2014 |
EXACTECH CERVICAL SPACER SYSTEM |
EXACTECH, INC. |
| K141333 |
05/21/2014 |
ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE |
SPINEFRONTIER, INC. |
| K141337 |
05/21/2014 |
ARENA-C |
SPINEFRONTIER, INC. |
| K141798 |
07/03/2014 |
SYPHER SPACER SYSTEM |
BIOGENNIX, LLC |
| K142026 |
07/25/2014 |
SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE |
SPINEFRONTIER, INC. |
| K180655 |
03/13/2018 |
Viking Lumbar Polyaxial Screw System |
Presidio Surgical |
| K183080 |
11/05/2018 |
Mega Plus Spine System |
BK Meditech Co., Ltd |
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