Panels › Orthopedic › Product code OUR · Class 2
Sacroiliac Joint Fixation
Regulation 888.3040
7510(k)s in 12 months (133 all time)
2recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in OUR
| Company | 510(k)s | Recalls |
|---|---|---|
| SI-BONE, Inc. | 27 | 1 |
| SurGenTec, LLC | 8 | 0 |
| Zyga Technology, Inc. | 6 | 0 |
| Life Spine, Inc. | 5 | 0 |
| Orthofix, Inc. | 5 | 0 |
| L&K BIOMED Co., Ltd. | 4 | 0 |
| Tenon Medical | 4 | 0 |
| Aegis Spine | 3 | 0 |
| Camber Spine Technologies | 3 | 0 |
| Cutting Edge Spine, LLC | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 5, 2017 | K170475 | SICAGE System Sicage, LLC | OUR |
| Mar 10, 2017 | K162733 | iFuse Implant System® - iFuse-3D implant SI-BONE, Inc. | OUR |
| Jan 18, 2017 | K162121 | Siconus SI Joint Fixation System Camber Spine Technologies | OUR |
| Dec 14, 2016 | K161755 | Integrity-SI TM Fusion System Coorstek Medical | OUR |
| Nov 14, 2016 | K153656 | PathLoc-SI Joint Fusion System L&K BIOMED Co., Ltd., KR | OUR |
| Aug 12, 2016 | K161210 | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Medtronic Sofamor Danek | OUR |
| Jun 3, 2016 | K160652 | iFUSE Implant System SI-BONE, Inc. | OUR |
| Mar 1, 2016 | K152681 | iFuse Implant System(R) SI-BONE, Inc. | OUR |
| Feb 4, 2016 | K152237 | The Entasis Dual-Lead Sacroiliac Implant Corelink, LLC | OUR |
| Oct 29, 2015 | K151718 | iFuse Implant System SI-BONE, Inc. | OUR |
| Aug 12, 2015 | K151462 | SI-TECHNOLOGY® SI-DESIS® SCREWS Si-Technology, LLC | OUR |
| Aug 5, 2015 | K151818 | SImmetry Sacroiliac Joint Fusion System Zyga Technology, Inc. | OUR |
| Jul 22, 2015 | K150875 | iFuse Implant System SI-BONE, Inc. | OUR |
| Apr 24, 2015 | K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System Spinefrontier, Inc. | OUR |
| Apr 17, 2015 | K150714 | SI-BONE iFuse Implant System SI-BONE, Inc. | OUR |
| Feb 22, 2015 | K141246 | LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM Life Spine, Inc. | OUR |
| Jan 15, 2015 | K141549 | SImmetry Sacroiliac Joint Fusion System Zyga Technology, Inc. | OUR |
| Oct 10, 2014 | K141106 | FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM Folsom Metal Products, Inc. Dba Frontier Devices | OUR |
| Jul 23, 2014 | K141049 | IFUSE IMPLANT SYSTEM SI-BONE, Inc. | OUR |
| Mar 25, 2014 | K140079 | SILEX SACROILIAC JOINT FUSION SYSTEM X-Spine Systems, Inc. | OUR |
| Oct 16, 2013 | K131405 | IFUSE IMPLANT SYSTEM SI-BONE, Inc. | OUR |
| Apr 1, 2013 | K123850 | IFUSE IMPLANT SYSTEM SI-BONE, Inc. | OUR |
| Mar 11, 2013 | K123702 | SILEX SACROILIAC JOINT FUSION SYSTEM X-Spine Systems, Inc. | OUR |
| Feb 27, 2013 | K130092 | SIMMETRY SACROILIAC JOINT FUSION SYSTEM Zyga Technology, Inc. | OUR |
| Oct 12, 2012 | K122074 | IFUSE IMPLANT SYSTEM SI-BONE, Inc. | OUR |
| May 29, 2012 | K110472 | SI-FIX SACROILIAC JOINT FUSION SYSTEM Medtronic Sofamor Danek | OUR |
| Jul 21, 2011 | K111801 | SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM Zyga Technology, Inc. | OUR |
| Apr 21, 2011 | K110838 | IFUSE IMPLANT SYSTEM SI-BONE, Inc. | OUR |
| Mar 23, 2011 | K110512 | SIMMETRY SACROILIAC JOINT FUSION SYSTEM Zyga Technology, Inc. | OUR |
| Dec 14, 2010 | K102907 | SIMMETRY SACROILIAC JOINT FUSION SYSTEM Zyga Technology, Inc. | OUR |
| Sep 4, 2009 | K092375 | MODIFICATION TO SI JOINT FUSION SYSTEM SI-BONE, Inc. | OUR |
| Nov 26, 2008 | K080398 | SI JOINT FUSION SYSTEM SI-BONE, Inc. | OUR |
| Aug 26, 2005 | K051296 | SIJF CANNULATED SCREW SYSTEM Depuy Spine, Inc. | OUR |
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