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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2019 | CTL Medical Corporation CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308. Completed |
MAX | K131981 |
| Aug 21, 2019 | CTL Medical Corporation CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907. Completed |
MAX | K131981 |
| Aug 21, 2019 | CTL Medical Corporation CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307. Completed |
MAX | K131981 |
| Apr 27, 2019 | DePuy Spine, Inc. Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L) Terminated |
MAX | K152156 K160464 |
| Apr 27, 2019 | DePuy Spine, Inc. Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C) Terminated |
MAX | K171425 |
| Dec 19, 2018 | XTANT MEDICAL INC Calix Lumbar Spinal Implant System:
22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC
22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC
26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC
26mm x 10mm x 8mm PL Terminated |
MAX | K170119 |
| Nov 28, 2018 | Howmedica Osteonics Corp. Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure. Terminated |
MAX | K152304 |
| Aug 13, 2018 | Stryker Spine AVS Aria Cage, Catalog Number 48753212
Product Usage:
The Stryker Spine AVS ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with d Terminated |
MAX | K151726 |
| Apr 16, 2018 | Spinal Elements AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11
The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion proc Open, Classified |
MAX | K150395 |
| Feb 27, 2018 | Integrity Implants Inc. FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with autogenous bone graf Terminated |
MAX | K160076 |
| Jan 18, 2018 | Neuropro Spinal Jaxx Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L
Product Usage:
The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative di Terminated |
MAX | K152501 |
| Jul 26, 2017 | DePuy Orthopaedics, Inc. Concorde Lift Driver Shaft AO.
Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine. Terminated |
MAX | K171425 |
| Mar 16, 2017 | Zimmer Biomet Spine, Inc Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216
The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-th Terminated |
MAX | None listed |
| Feb 27, 2017 | Kiscomedica S.A. L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France.
Product Usage:
The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally matur Terminated |
MAX | K080537 |
| Jan 3, 2017 | Interventional Spine Inc G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06
The Opticage Expandable Interbody Fusion Device is a posterior lumbar interverte Terminated |
MAX | K152156 K160464 |
| Dec 20, 2016 | Amendia, Inc Zeus-P Lumbar Interbody Device Terminated |
MAX | K151322 |
| Jul 26, 2016 | Howmedica Osteonics Corp. AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancello Terminated |
MAX | K132505 K141217 +1 |
| Jul 26, 2016 | Howmedica Osteonics Corp. AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellou Terminated |
MAX | K132505 K141217 +1 |
| Jul 26, 2016 | Howmedica Osteonics Corp. AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous Terminated |
MAX | K132505 K141217 +1 |
| Jul 7, 2016 | Zimmer Trabecular Metal Technology, Inc. The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and Terminated |
MAX | K113561 |
| Jun 30, 2016 | Zimmer Biomet Spine, Inc Zyston Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile. Terminated |
MAX | K153695 |
| Jun 30, 2016 | Zimmer Biomet Spine, Inc Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile. Terminated |
MAX | K153695 |
| May 17, 2016 | X Spine Systems Inc Calix T PEEK Lumbar System, TLIF Trial Terminated |
MAX | K131350 |
| May 17, 2016 | X Spine Systems Inc Calix T PEEK Lumbar System, TLIF Rasp Terminated |
MAX | K131350 |
| May 17, 2016 | X Spine Systems Inc Calix P PEEK Lumbar System, PLIF Trial Terminated |
MAX | K131350 |
| May 17, 2016 | X Spine Systems Inc Calix P PEEK Lumbar System, PLIF Rasp Terminated |
MAX | K131350 |
| Feb 18, 2016 | Synthes (USA) Products LLC Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve
Product Usage - The OPAL Spacer is indicated for use in Terminated |
MAX | K072791 |
| Dec 16, 2015 | Stryker Spine AccuLIF PL Tubing Set and AccuLIF TL Tubing Set
AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. The purpose of the AccuLIF PL Tubing Set (cat#900301 Terminated |
MAX | K143616 |
| Jun 26, 2015 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13- Terminated |
MAX | K133455 |
| Feb 9, 2015 | Biomet Spine, LLC Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Ti Terminated |
MAX | None listed |
| Jan 5, 2015 | Spinal Elements, Inc Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000
This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months no Terminated |
MAX | K110632 |
| Dec 16, 2014 | 4-Web Inc. ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (ort Terminated |
MAX | K112316 |
| Dec 16, 2014 | Biomet Spine LLC. LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case.
Product Usage:
The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in Terminated |
MAX | K102738 |
| Nov 18, 2014 | Medacta Usa The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants. Terminated |
MAX | K110927 |
| May 7, 2014 | SpineFrontier, Inc. SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, I Terminated |
MAX | K092815 |
| Sep 27, 2013 | Ebi, Llc Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device. Terminated |
MAX | K093629 |
| Sep 19, 2013 | Spine Smith Holdings, LLC VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410.
Intended to be implanted via an open anterior Terminated |
MAX | K102090 |
| Sep 11, 2013 | Spine Wave, Inc. StaXx IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902.
Indicated for intervertebral body fusion procedures in skeletally mature patients. Terminated |
MAX | K123461 |
| Jul 25, 2013 | Aesculap, Inc. ProSpace Peek Implant 5 degree x 8.5 x 22 mm
The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Terminated |
MAX | K071983 |
| May 27, 2013 | Spinal Solutions, LLC Copperhead IBFD, Large Neutral, 6mm
Copperhead IBFD, Large Neutral, 7mm
Copperhead IBFD, Large Neutral, 8mm
Copperhead IBFD, Large Neutral, 9mm
Copperhead IBFD, Large Neutral, 10mm
Copperhead IBF Terminated |
MAX | K090064 |
| Apr 22, 2013 | Spinal Solutions, LLC APLIF Implants and Instruments,
Part Numbers:
184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree
184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree
184012-10 Anterior Psoas Lumbar 18 Terminated |
MAX | None listed |
| Mar 10, 2013 | Spine Smith Partners LP Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation. Terminated |
MAX | K101085 |
| Jan 9, 2013 | Zimmer, Inc. The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only.
The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The i Terminated |
MAX | K113561 |
| Dec 22, 2012 | Zimmer, Inc. Zimmer Spine Ardis Inserter, Rx, non-sterile Terminated |
MAX | K073202 |
| Nov 21, 2012 | SpineFrontier, Inc. S-Lift Implant Guides (also known as S-LIF)
Compressor Part Number: 11-50223
Product Usage:
Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, witho Terminated |
MAX | K092815 |
| Jun 7, 2012 | Captiva Spine, Inc Accessories for the Captiva Spine FuseLOX Lumbar Cage.
The FuseLOX Lumbar Inserter product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an i Terminated |
MAX | None listed |
| Jun 7, 2012 | Captiva Spine, Inc Accessories for the Captiva Spine FuseLOX Lumbar Cage.
The Trial product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packag Terminated |
MAX | None listed |
| Jun 7, 2012 | Captiva Spine, Inc Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX Lumbar Cage Lumbar Interbody Fusion Device***Description:***Part Number:***Lot Number:***Quantity: 1* Terminated |
MAX | None listed |
| Jun 7, 2012 | Captiva Spine, Inc Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX Lumbar Cage Lumbar Interbody Fusion Device***Description:***Part Number:***Lot Number:***Quantity: 1* Terminated |
MAX | None listed |
| Jun 1, 2012 | Genesys Orthopedic Systems, LLC Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion System.
The TLIF PEEK inserter is used to introduce the TLIF PEEK implant into the patien Terminated |
MAX | K103034 |
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