FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K203373 |
Advanced Research Medical, LLC |
Advanced Research Medical Trident SI Screw System |
01/22/2021 |
K210035 |
Aegis Spine |
ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System |
02/16/2021 |
K223521 |
Aegis Spine, Inc. |
ZESPIN SI Joint Fusion System |
01/20/2023 |
K221050 |
Aegis Spine, Inc. |
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System |
06/30/2022 |
K231951 |
Alevio, LLC |
SI-Cure Sacroiliac Joint Fusion System |
07/28/2023 |
K223819 |
Alevio, LLC |
SI-Cure Sacroiliac Joint Fusion System |
01/18/2023 |
K220274 |
Anjali Investments L.L.C |
Kisar Stratford SI Screw System |
04/24/2023 |
K221047 |
Aurora Spine, Inc. |
SILO TFX MIS Sacroiliac Joint Fixation System |
10/03/2022 |
K200868 |
Biofusion Medical |
SI-Restore Sacroiliac Joint Fixation System |
04/17/2020 |
K182919 |
Biofusion Medical |
SI-Restore« Sacroiliac Joint Fixation System |
01/25/2019 |
K162121 |
CAMBER SPINE TECHNOLOGIES |
Siconus SI Joint Fixation System |
01/18/2017 |
K203503 |
Camber Spine Technologies, LLC |
Camber Sacroiliac (SI) Fixation System |
09/02/2022 |
K211449 |
ChoiceSpine, LLC |
TritonÖ Sacroiliac Joint Fixation System |
08/31/2021 |
K161755 |
CoorsTek Medical |
Integrity-SI TM Fusion System |
12/14/2016 |
K223708 |
CoreLink, LLC |
Entasis 3D Dual-Lead Sacroiliac Implant System |
03/21/2023 |
K152237 |
CoreLink, LLC |
The Entasis Dual-Lead Sacroiliac Implant |
02/04/2016 |
K211785 |
CTL Medical Corporation |
CASSATTÖ SIJ Fixation System |
10/17/2022 |
K210402 |
Curiteva, Inc. |
Curiteva Sacroiliac Joint Fusion System |
09/09/2021 |
K190025 |
Cutting Edge Spine, LLC |
EVOL« -SI Joint Fusion System |
08/12/2019 |
K214123 |
Cutting Edge Spine, LLC |
T-FIX« 3DSI Joint Fusion System |
06/24/2022 |
K230689 |
Cutting Edge Spine, LLC |
T-FIXÖ 3DSI Joint Fusion System |
04/05/2023 |
K051296 |
DEPUY SPINE, INC. |
SIJF CANNULATED SCREW SYSTEM |
08/26/2005 |
K222448 |
Dio Medical Corporation |
UNITY Sacroiliac Joint Fixation System |
10/13/2022 |
K141106 |
FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES |
FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM |
10/10/2014 |
K211496 |
Foundation Fusion Solutions, LLC (dba CornerLoc) |
TransLoc 3D |
07/27/2022 |
K191748 |
Genesys Spine |
Genesys Spine Sacroiliac Joint Fusion System |
09/26/2019 |
K183119 |
Globus Medical Inc. |
SI-LOK« Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS« Instruments |
02/06/2019 |
K231829 |
HT Medical d.b.a. Xenix Medical |
Xenix Medical Sacroiliac Fixation System |
08/15/2023 |
K173201 |
Huvexel Co., Ltd |
UNITY Sacroiliac Joint Fixation System |
04/26/2018 |
K190580 |
Ilion Medical Inc |
NADIA SI Fusion System |
08/05/2020 |
K231841 |
L & K Biomed Co., Ltd. |
PathLoc SI Joint Fusion System |
07/14/2023 |
K153656 |
L&K BIOMED Co., Ltd. |
PathLoc-SI Joint Fusion System |
11/14/2016 |
K181600 |
L&K BIOMED Co., Ltd. |
PathLoc-SI Joint Fusion System |
07/16/2018 |
K232605 |
LESspine Innovations |
Sacrix« Sacroiliac Joint Fusion Device System, Inspan« ScrewLES Fusion System, Invue« MAXÖ + Invue Inset Anterior Cervical Plate System, and FacetFuse« Screw Fixation System |
09/28/2023 |
K180749 |
Life Spine Inc. |
Life Spine SIMPACT Sacroiliac Joint Fixation System |
06/15/2018 |
K201538 |
Life Spine Inc. |
Life Spine SIMPACT Sacroiliac Joint Fixation System |
09/18/2020 |
K141246 |
LIFE SPINE, INC |
LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM |
02/22/2015 |
K212903 |
Life Spine, Inc. |
SIMPACT Sacroiliac Joint Fixation System |
12/15/2021 |
K171595 |
Medacta International SA |
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System |
08/02/2017 |
K203671 |
Medacta International SA |
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System |
01/13/2021 |
K193083 |
Medacta International SA |
M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System |
12/03/2019 |
K161210 |
Medtronic Sofamor Danek |
RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems |
08/12/2016 |
K110472 |
MEDTRONIC SOFAMOR DANEK |
SI-FIX SACROILIAC JOINT FUSION SYSTEM |
05/29/2012 |
K200696 |
Orthofix Inc. |
FIREBIRD SI Fusion System |
04/02/2020 |
K201664 |
Orthofix Inc. |
FIREBIRD SI Fusion System |
09/15/2020 |
K203138 |
Orthofix Inc. |
FIREBIRD SI Fusion System |
11/18/2020 |
K210667 |
Orthofix Inc. |
FIREBIRD SI Fusion System |
03/25/2021 |
K183342 |
Orthofix Inc. |
SambaScrew 3D SI Fusion System |
04/30/2019 |
K212962 |
OrthoFundamentals, LLC |
TRELLISÖ SI Joint Fusion System |
04/11/2022 |
K213590 |
Osseus Fusion Systems, LLC |
Blue Topaz Sacroiliac Screw System |
03/01/2022 |
K222512 |
OsteoCentric Technologies |
Integrity-SI Fusion System |
09/12/2022 |
K230226 |
OsteoCentric Technologies |
Integrity-SI« Fusion System |
09/21/2023 |
K193524 |
Si-Bone, Inc |
SI-BONE iFuse Implant System« |
03/31/2020 |
K222774 |
SI-BONE, Inc. |
iFuse Bedrock Granite« Implant System |
12/22/2022 |
K220195 |
SI-BONE, Inc. |
iFuse Bedrock GraniteÖ Implant System |
05/26/2022 |
K123850 |
SI-BONE, INC. |
IFUSE IMPLANT SYSTEM |
04/01/2013 |
K131405 |
SI-BONE, INC. |
IFUSE IMPLANT SYSTEM |
10/16/2013 |
K110838 |
SI-BONE, INC. |
IFUSE IMPLANT SYSTEM |
04/21/2011 |
K141049 |
SI-BONE, INC. |
IFUSE IMPLANT SYSTEM |
07/23/2014 |
K122074 |
SI-BONE, INC. |
IFUSE IMPLANT SYSTEM |
10/12/2012 |
K160652 |
SI-BONE, INC. |
iFUSE Implant System |
06/03/2016 |
K150875 |
SI-BONE, Inc. |
iFuse Implant System |
07/22/2015 |
K151718 |
SI-BONE, INC. |
iFuse Implant System |
10/29/2015 |
K182983 |
SI-BONE, Inc. |
iFuse Implant System« |
11/27/2018 |
K190230 |
SI-BONE, Inc. |
iFuse Implant System« |
04/03/2019 |
K162733 |
SI-BONE, INC. |
iFuse Implant System« - iFuse-3D implant |
03/10/2017 |
K152681 |
SI-BONE, INC. |
iFuse Implant System(R) |
03/01/2016 |
K231689 |
Si-Bone, Inc. |
iFuse TORQ« Implant System |
06/30/2023 |
K222605 |
SI-BONE, Inc. |
iFuse TORQ« Implant System |
09/29/2022 |
K213667 |
SI-BONE, Inc. |
iFuse-TORQ« Implant System |
06/10/2022 |
K203247 |
SI-BONE, Inc. |
iFuse-TORQÖ Implant System |
02/25/2021 |
K092375 |
SI-BONE, INC. |
MODIFICATION TO SI JOINT FUSION SYSTEM |
09/04/2009 |
K080398 |
SI-BONE, INC. |
SI JOINT FUSION SYSTEM |
11/26/2008 |
K150714 |
SI-BONE, Inc. |
SI-BONE iFuse Implant System |
04/17/2015 |
K151462 |
SI-TECHNOLOGY, LLC |
SI-TECHNOLOGY« SI-DESIS« SCREWS |
08/12/2015 |
K170475 |
Sicage LLc |
SICAGEÖ System |
05/05/2017 |
K181881 |
SIJ Surgical |
Outlet Sacroiliac Joint Fusion System |
10/03/2018 |
K150017 |
SpineFrontier, Inc. |
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System |
04/24/2015 |
K203780 |
Spinus International, Inc. |
Harvester SI: Sacroiliac Fixation System |
03/23/2021 |
K231831 |
SurGenTec |
TiLink-L Joint Fusion System |
08/03/2023 |
K230446 |
Surgentec, LLC |
TiLink-L SI Joint Fusion System |
06/07/2023 |
K230857 |
Surgentec, LLC |
TiLink-P SI Joint Fusion System |
09/25/2023 |
K180818 |
Tenon Medical, Inc. |
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) |
06/13/2018 |
K231944 |
Tenon Medical, Inc. |
CATAMARAN SI Joint Fusion System |
08/24/2023 |
K213815 |
VGI Medical, Inc. |
SiJoin«T3 |
03/29/2023 |
K140079 |
X-SPINE SYSTEMS, INC |
SILEX SACROILIAC JOINT FUSION SYSTEM |
03/25/2014 |
K123702 |
X-SPINE SYSTEMS, INC. |
SILEX SACROILIAC JOINT FUSION SYSTEM |
03/11/2013 |
K173752 |
Zavation Medical Products, LLC |
SI Screw System |
03/16/2018 |
K141549 |
Zyga Technology, Inc. |
SImmetry Sacroiliac Joint Fusion System |
01/15/2015 |
K151818 |
Zyga Technology, Inc. |
SImmetry Sacroiliac Joint Fusion System |
08/05/2015 |
K130092 |
Zyga Technology, Inc. |
SIMMETRY SACROILIAC JOINT FUSION SYSTEM |
02/27/2013 |
K102907 |
Zyga Technology, Inc. |
SIMMETRY SACROILIAC JOINT FUSION SYSTEM |
12/14/2010 |
K110512 |
Zyga Technology, Inc. |
SIMMETRY SACROILIAC JOINT FUSION SYSTEM |
03/23/2011 |
K111801 |
Zyga Technology, Inc. |
SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM |
07/21/2011 |