FDA 510(k) Applications Submitted by SPINEOLOGY, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| DEN200010 |
02/19/2020 |
Spineology Interbody Fusion System |
Spineology, Inc. |
| K191091 |
04/24/2019 |
Rampart One Lumbar Interbody Fusion System |
Spineology, Inc. |
| K192047 |
07/31/2019 |
RampartÖ One Lumbar Interbody Fusion System |
Spineology, Inc. |
| K120293 |
01/31/2012 |
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE |
SPINEOLOGY, INC. |
| K130396 |
02/19/2013 |
RAMPART O AND RAMPART P |
SPINEOLOGY, INC. |
| K110933 |
04/04/2011 |
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE |
SPINEOLOGY, INC. |
| K121129 |
04/13/2012 |
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE |
SPINEOLOGY, INC. |
| K131216 |
04/30/2013 |
RAMPART O |
SPINEOLOGY, INC. |
| K132053 |
07/03/2013 |
RAMPART-O, RAMPART-T |
SPINEOLOGY, INC. |
| K113030 |
10/12/2011 |
SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE |
SPINEOLOGY, INC. |
| K123232 |
10/16/2012 |
SPINEOLOGY SPINOUS PROCESS PLATE |
SPINEOLOGY, INC. |
| K133371 |
11/01/2013 |
RAMPART-L |
SPINEOLOGY, INC. |
| K123652 |
11/27/2012 |
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE |
SPINEOLOGY, INC. |
| K153082 |
10/23/2015 |
Rampart A Lumbar Interbody Fusion Device |
SPINEOLOGY, INC. |
| K153323 |
11/18/2015 |
Palisade Pedicular Fixation System |
SPINEOLOGY, INC. |
| K140010 |
01/02/2014 |
FORTRESS PEDICLE SCREW SYSTEM |
SPINEOLOGY, INC. |
| K152148 |
08/03/2015 |
Fortress Pedicular Fixation System |
SPINEOLOGY, INC. |
| K092464 |
08/11/2009 |
SPINEOLOGY FACET SCREW |
SPINEOLOGY, INC. |
| K990959 |
03/22/1999 |
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM |
SPINEOLOGY, INC. |
| K002371 |
07/27/2000 |
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM |
SPINEOLOGY, INC. |
| K033953 |
12/22/2003 |
OPTIMESH 500E CEMENT RESTRICTOR |
SPINEOLOGY, INC. |
| K014200 |
12/21/2001 |
OPTIMESH |
SPINEOLOGY, INC. |
| K151020 |
04/16/2015 |
Rampart-T Interbody Fusion System |
Spineology, Inc. |
| K142213 |
08/12/2014 |
VIA SPINOUS PROCESS FIXATION SYSTEM |
SPINEOLOGY, INC. |
| K143403 |
11/28/2014 |
Threshold Pedicular Fixation System |
Spineology, Inc. |
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