ClearanceBrief
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)
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Top companies in MAX

DateFirm and productCodeLinked 510(k)
Aug 21, 2019CTL Medical Corporation
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.
Completed
MAXK131981
Aug 21, 2019CTL Medical Corporation
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.
Completed
MAXK131981
Aug 21, 2019CTL Medical Corporation
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.
Completed
MAXK131981
Apr 27, 2019DePuy 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
MAXK152156
K160464
Apr 27, 2019DePuy Spine, Inc.
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
Terminated
MAXK171425
Dec 19, 2018XTANT 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
MAXK170119
Nov 28, 2018Howmedica 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
MAXK152304
Aug 13, 2018Stryker 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
MAXK151726
Apr 16, 2018Spinal 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
MAXK150395
Feb 27, 2018Integrity 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
MAXK160076
Jan 18, 2018Neuropro 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
MAXK152501
Jul 26, 2017DePuy 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
MAXK171425
Mar 16, 2017Zimmer 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
MAXNone listed
Feb 27, 2017Kiscomedica 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
MAXK080537
Jan 3, 2017Interventional 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
MAXK152156
K160464
Dec 20, 2016Amendia, Inc
Zeus-P Lumbar Interbody Device
Terminated
MAXK151322
Jul 26, 2016Howmedica 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
MAXK132505
K141217 +1
Jul 26, 2016Howmedica 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
MAXK132505
K141217 +1
Jul 26, 2016Howmedica 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
MAXK132505
K141217 +1
Jul 7, 2016Zimmer 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
MAXK113561
Jun 30, 2016Zimmer Biomet Spine, Inc
Zyston Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
Terminated
MAXK153695
Jun 30, 2016Zimmer Biomet Spine, Inc
Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Terminated
MAXK153695
May 17, 2016X Spine Systems Inc
Calix T PEEK Lumbar System, TLIF Trial
Terminated
MAXK131350
May 17, 2016X Spine Systems Inc
Calix T PEEK Lumbar System, TLIF Rasp
Terminated
MAXK131350
May 17, 2016X Spine Systems Inc
Calix P PEEK Lumbar System, PLIF Trial
Terminated
MAXK131350
May 17, 2016X Spine Systems Inc
Calix P PEEK Lumbar System, PLIF Rasp
Terminated
MAXK131350
Feb 18, 2016Synthes (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
MAXK072791
Dec 16, 2015Stryker 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
MAXK143616
Jun 26, 2015RTI 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
MAXK133455
Feb 9, 2015Biomet 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
MAXNone listed
Jan 5, 2015Spinal 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
MAXK110632
Dec 16, 20144-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
MAXK112316
Dec 16, 2014Biomet 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
MAXK102738
Nov 18, 2014Medacta Usa
The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
Terminated
MAXK110927
May 7, 2014SpineFrontier, 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
MAXK092815
Sep 27, 2013Ebi, Llc
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
Terminated
MAXK093629
Sep 19, 2013Spine 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
MAXK102090
Sep 11, 2013Spine 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
MAXK123461
Jul 25, 2013Aesculap, 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
MAXK071983
May 27, 2013Spinal 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
MAXK090064
Apr 22, 2013Spinal 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
MAXNone listed
Mar 10, 2013Spine Smith Partners LP
Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.
Terminated
MAXK101085
Jan 9, 2013Zimmer, 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
MAXK113561
Dec 22, 2012Zimmer, Inc.
Zimmer Spine Ardis Inserter, Rx, non-sterile
Terminated
MAXK073202
Nov 21, 2012SpineFrontier, 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
MAXK092815
Jun 7, 2012Captiva 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
MAXNone listed
Jun 7, 2012Captiva 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
MAXNone listed
Jun 7, 2012Captiva 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
MAXNone listed
Jun 7, 2012Captiva 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
MAXNone listed
Jun 1, 2012Genesys 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
MAXK103034

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