Premarket Reviews |
Manufacturer | Decision |
ADVANCED RESEARCH MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AEGIS SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AEGIS SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALEVIO, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ANJALI INVESTMENTS L.L.C |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASTURA MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AURORA SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOFUSION MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CAMBER SPINE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CAMBER SPINE TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHOICESPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COORSTEK MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORELINK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CTL MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CURITEVA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CUTTING EDGE SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DELTACOR GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIO MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOUNDATION FUSION SOLUTIONS, LLC (DBA CORNERLOC) |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GENESYS SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HT MEDICAL D.B.A. XENIX MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HT MEDICAL LLC DBA XENIX MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUVEXEL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ILION MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
L & K BIOMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
L&K BIOMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
LESSPINE INNOVATIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LIFE SPINE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDTRONIC SOFAMOR DANEK |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOFIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ORTHOFUNDAMENTALS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSEUS FUSION SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSTEOCENTRIC TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SAIL FUSION, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SI-BONE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K092375 MODIFICATION TO SI JOINT FUSION SYSTEM
|
2. K110838 IFUSE IMPLANT SYSTEM
|
3. K122074 IFUSE IMPLANT SYSTEM
|
4. K123850 IFUSE IMPLANT SYSTEM
|
5. K131405 IFUSE IMPLANT SYSTEM
|
6. K141049 IFUSE IMPLANT SYSTEM
|
7. K150714 SI-BONE iFuse Implant System
|
8. K150875 iFuse Implant System
|
9. K151718 iFuse Implant System
|
10. K152681 iFuse Implant System(R)
|
11. K160652 iFUSE Implant System
|
12. K162733 iFuse Implant System® - iFuse-3D implant
|
13. K182983 iFuse Implant System®
|
14. K190230 iFuse Implant System®
|
15. K203247 iFuse-TORQ™ Implant System
|
16. K213667 iFuse-TORQ® Implant System
|
17. K220195 iFuse Bedrock Granite™ Implant System
|
18. K222605 iFuse TORQ® Implant System
|
19. K222774 iFuse Bedrock Granite® Implant System
|
20. K231689 iFuse TORQ® Implant System
|
21. K233508 iFuse Bedrock Granite® Implant System
|
SI-BONE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
21
|
1. K092375 MODIFICATION TO SI JOINT FUSION SYSTEM
|
2. K110838 IFUSE IMPLANT SYSTEM
|
3. K122074 IFUSE IMPLANT SYSTEM
|
4. K123850 IFUSE IMPLANT SYSTEM
|
5. K131405 IFUSE IMPLANT SYSTEM
|
6. K141049 IFUSE IMPLANT SYSTEM
|
7. K150714 SI-BONE iFuse Implant System
|
8. K150875 iFuse Implant System
|
9. K151718 iFuse Implant System
|
10. K152681 iFuse Implant System(R)
|
11. K160652 iFUSE Implant System
|
12. K162733 iFuse Implant System® - iFuse-3D implant
|
13. K182983 iFuse Implant System®
|
14. K190230 iFuse Implant System®
|
15. K203247 iFuse-TORQ™ Implant System
|
16. K213667 iFuse-TORQ® Implant System
|
17. K220195 iFuse Bedrock Granite™ Implant System
|
18. K222605 iFuse TORQ® Implant System
|
19. K222774 iFuse Bedrock Granite® Implant System
|
20. K231689 iFuse TORQ® Implant System
|
21. K233508 iFuse Bedrock Granite® Implant System
|
SI-TECHNOLOGY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SICAGE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIJ SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL SIMPLICITY LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINEFRONTIER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINUS INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGENTEC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGENTEC, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TENON MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VGI MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-SPINE SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-SPINE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZAVATION MEDICAL PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZYGA TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|