Panels › Orthopedic › Product code MAX · Class 2
Intervertebral Fusion Device With Bone Graft, Lumbar
Regulation 888.3080
20510(k)s in 12 months (897 all time)
5recalls in 12 months (116 all time)
105recalls that name a 510(k)
Top companies in MAX
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 55 | 12 |
| Globus Medical, Inc. | 20 | 22 |
| Nu Vasive, Incorporated | 34 | 0 |
| Life Spine | 33 | 0 |
| Alphatec Spine | 22 | 3 |
| Spineology, Inc. | 22 | 0 |
| SeaSpine Orthopedics Corporation | 20 | 1 |
| Spinal Elements | 17 | 2 |
| Stryker | 17 | 0 |
| K2m | 13 | 3 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 23, 2020 | K191788 | CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGE Medtronic Sofamor Danek USA, Inc. | MAX |
| Mar 13, 2020 | K193418 | SeaSpine Skipjack System SeaSpine Orthopedics Corporation | MAX |
| Mar 9, 2020 | K200048 | MectaLIF Anterior Simple Medacta International S.A., CH | MAX |
| Mar 2, 2020 | K193378 | CarboClear Lumbar Cage System CarboFix Orthopedics , Ltd., IL | MAX |
| Feb 21, 2020 | K190363 | Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiB Omnia Medical, LLC | MAX |
| Feb 20, 2020 | K193255 | Largo PEEK Interbody System Flospine, LLC | MAX |
| Feb 18, 2020 | K193203 | MOJAVE Expandable Interbody System K2m, Inc. | MAX |
| Feb 6, 2020 | K193521 | Steerable Plateau Ti Life Spine, Inc. | MAX |
| Jan 31, 2020 | K193258 | ProLift Expandable System Life Spine, Inc. | MAX |
| Jan 22, 2020 | K192502 | Anatomic PEEK Cervical Fusion System, Anatomic PEEK PTC Cervical Fusion System, Capstone Spinal System, Capstone PTC Medtronic Sofamor Danek USA, Inc. | MAX |
| Jan 21, 2020 | K193370 | Nexxt Matrixx System Nexxt Spine, LLC | MAX |
| Jan 14, 2020 | K192115 | SABLE Expandable Spacer Globus Medical, Inc. | MAX |
| Jan 13, 2020 | K193645 | nva, nvp, and nvt Nvision Biomedical Technologies, Inc. | MAX |
| Jan 9, 2020 | K192687 | TrellOss-L MPF Nexxt Spine, LLC | MAX |
| Jan 6, 2020 | K192497 | EVOL ha - D Lateral Interbody Fusion System Cutting Edge Spine, LLC | MAX |
| Dec 20, 2019 | K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | MAX |
| Dec 16, 2019 | K193174 | Keos Lumbar IBFD Keos | MAX |
| Dec 16, 2019 | K181548 | Pantheon Spinal Pontus Interbody Fusion Device Pantheon Spinal | MAX |
| Dec 13, 2019 | K191796 | Neo Cage System Neo Medical SA, CH | MAX |
| Dec 12, 2019 | K182987 | Genesys Spine 3DP Lumbar Interbody System Genesys Spine | MAX |
| Dec 3, 2019 | K192132 | SeaSpine Beachside System SeaSpine Orthopedics Corporation | MAX |
| Nov 26, 2019 | K192026 | Peridot Intervertebral body fusion System Gbs Commonwealth Co., Ltd., KR | MAX |
| Nov 25, 2019 | K192248 | Cortina [MAX] Lumbar Cage System Neurostructures, Inc. | MAX |
| Nov 14, 2019 | K190721 | LongBow Ti Life Spine, Inc. | MAX |
| Nov 1, 2019 | K190544 | XIHPOS ZFUZE Interbody Fusion System Difusion Technologies | MAX |
| Oct 30, 2019 | K191134 | IB3D ALIF Medicrea International SA, FR | MAX |
| Oct 28, 2019 | K180347 | 3d Cage Fims Co., Ltd., KR | MAX |
| Oct 18, 2019 | K192760 | NuVasive Modulus XLIF Interbody System Nu Vasive, Incorporated | MAX |
| Oct 15, 2019 | K192434 | DualX Lumbar Intervertebral Body Fusion Device Amplify Surgical, Inc. | MAX |
| Sep 25, 2019 | K191791 | TranS1 Interbody Fusion System Trans1 | MAX |
| Sep 23, 2019 | K190483 | SPIRA Open Matrix ALIF and LLIF Camber Spine Technologies | MAX |
| Sep 18, 2019 | K191391 | HEDRON Lumbar Spacers Globus Medical, Inc. | MAX |
| Sep 18, 2019 | K190563 | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Solco Biomedical Co., Ltd., KR | MAX |
| Sep 16, 2019 | K190708 | AccelFix Lumbar Interbody Fusion Cage System L&K BIOMED Co., Ltd., KR | MAX |
| Sep 12, 2019 | K191516 | Ali Interbody Fusion System Raed M. Ali, M.D., Inc. | MAX |
| Sep 12, 2019 | K190398 | Republic Spine Restore Intervertebral Body Fusion System Republic Spine, LLC | MAX |
| Aug 30, 2019 | K183407 | Triton Cage Medyssey USA, Inc. | MAX |
| Aug 19, 2019 | K191339 | Zavation eZspand Interbody System Zavation Medical Products, LLC | MAX |
| Aug 12, 2019 | K191311 | ATEC Lateral Interbody System Alphatec Spine, Inc. | MAX |
| Jul 25, 2019 | K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage Stryker Spine | MAX |
| Jul 23, 2019 | K190488 | ProLift Expandable System Life Spine, Inc. | MAX |
| Jul 18, 2019 | K190680 | FAVO S-TLIF Silony Medical GmbH, DE | MAX |
| Jul 15, 2019 | K182158 | UNiD Patient-matched PLIF cage Medicrea International SA, FR | MAX |
| Jul 10, 2019 | K191408 | Nexxt Matrixx System Nexxt Spine, LLC | MAX |
| Jul 10, 2019 | K183243 | Velofix TLIF Cage U&I Corporation, KR | MAX |
| Jul 5, 2019 | K191367 | Harrier-SA Lumbar Interbody System Choice Spine, LLC | MAX |
| Jul 5, 2019 | K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®- Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | MAX |
| Jul 3, 2019 | K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology Medtronic Sofamor Danek USA, Inc. | MAX |
| Jun 28, 2019 | K183064 | TxTi IBF System Innovasis, Inc. | MAX |
| Jun 17, 2019 | K190684 | LxHA PEEK Lateral IBF System Innovasis, Inc. | MAX |
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