FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K222097 |
Astura Medical |
OLYMPIC Deformity Band System |
05/04/2023 |
K172206 |
Cousin Biotech S.A.S. |
NAJAÖ Ligament Correction System |
04/10/2018 |
K181799 |
Cousin Biotech S.A.S. |
ResCUBEÖ Ligament Fixation System |
08/29/2018 |
K230565 |
Globus Medical Inc. |
HILINEÖ Fixation System |
04/20/2023 |
K172417 |
Globus Medical Inc. |
SILC« Fixation System |
10/26/2017 |
K133482 |
GLOBUS MEDICAL, INC. |
SILC FIXATION SYSTEM |
05/21/2014 |
K132287 |
HOGAN LOVELLS US LLP |
JAZZ SYSTEM |
09/25/2013 |
K133617 |
IMPLANET S.A. |
JAZZ SYSTEM |
02/20/2014 |
K143759 |
IMPLANET S.A. |
JAZZ System |
05/07/2015 |
K153348 |
Implanet, S.A. |
JAZZ LOCK |
03/31/2016 |
K171881 |
Implanet, S.A. |
JAZZ Passer Band |
08/08/2017 |
K191217 |
Implanet, S.A. |
JAZZ PF |
08/02/2019 |
K151740 |
Implanet, S.A. |
JAZZ System |
08/27/2015 |
K170730 |
Implanet, S.A. |
JAZZ System, including JAZZ Band |
06/09/2017 |
K143350 |
K2M, Inc. |
Nile Alternative Fixation |
02/25/2015 |
K160208 |
K2M, Inc. |
NILE Alternative Fixation Spinal System |
03/18/2016 |
K161332 |
K2M, INC. |
NILE Proximal Fixation Spinal System |
04/05/2017 |
K132395 |
MEDICREA INTERNATIONAL |
LIGAPASS |
12/06/2013 |
K213659 |
Medicrea International S. A. |
LigaPASSÖ 2.0 Ligament Augmentation System |
05/24/2022 |
K160698 |
MEDICREA INTERNATIONAL S.A. |
LigaPASS |
09/02/2016 |
K172021 |
Medicrea International S.A. |
LigaPASS |
08/30/2017 |
K173506 |
Medicrea International S.A. |
LigaPASS |
04/03/2018 |
K163181 |
Medtronic Sofamor Danek USA, Inc. |
TRANSLACEÖ Spinal Tethering System |
05/16/2017 |
K211057 |
Medtronic, Inc. |
LigaPASS« Spinal System, CD HorizonÖ Spinal System |
05/27/2021 |
K173117 |
NuVasive, Inc. |
NuVasive« VersaTieÖ System |
12/07/2017 |
K161265 |
NUVASIVE, INCORPORATED |
NuVasive« VersaTie System |
07/15/2016 |
K190418 |
NuVasive, Incorporated |
NuVasive« VersaTie« System |
03/21/2019 |
K200281 |
Ortho Development Corporation |
The Gecko Spinal System |
03/31/2020 |
K161267 |
ORTHOPEDIATRICS CORP. |
Response BandLoc Spinal Fixation |
08/11/2016 |
K200097 |
OrthoPediatrics Corp. |
Response BandLoc Spinal Fixation |
03/16/2020 |
K201240 |
SeaSpine Orthopedics Corporation |
Mariner Cap System |
08/05/2020 |
K190289 |
Spinal Elements Inc |
Karma« Fixation System |
04/03/2019 |
K180728 |
Spinal Elements Inc |
Spinal Elements Cerclage System |
09/06/2018 |
K110348 |
ZIMMER SPINE |
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM |
08/11/2011 |
K142053 |
ZIMMER SPINE, INC. |
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM |
10/29/2014 |