Primary Device ID | 10840642107975 |
NIH Device Record Key | 6d1b412f-69fe-4e75-9665-dc27cbaecdc3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Leva® Spacer System |
Version Model Number | 10-7131.2 |
Catalog Number | 10-7131.2 |
Company DUNS | 067789763 |
Company Name | Spine Wave, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 203-944-9494 |
GUDID@spinewave.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10840642107975 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10840642107975]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2017-05-17 |
10840642125399 | PX Brown Link Assembly, Tabbed |
10840642125382 | PX Purple Link Assembly, Tabbed |
10840642125375 | PX Blue Link Assembly, Tabbed |
10840642125368 | PX Green Link Assembly, Tabbed |
10840642125351 | PX White Link Assembly, Tabbed |
10840642117370 | PX White Inserter Assembly |
10840642117363 | PX Green/Blue Inserter Assembly |
10840642117356 | PX Purple/Brown Inserter Assembly |
10840642108095 | Leva® PX Inner Shaft Assembly 22mm 7-8-9mm |
10840642108088 | Leva® PX Outer Handle Assembly 22mm X 7-8-9mm |
10840642108071 | Leva® PX Expander Assy., 7, 8, 9mm |
10840642108064 | Leva® PX Inserter, 25 x 7, 8, 9mm |
10840642108057 | Leva® PX Link Assembly, Blue |
10840642108040 | Leva® PX Link Assembly, Bronze |
10840642108033 | Leva® PX Link Assembly |
10840642108026 | Leva® PX Inserter Assembly |
10840642108019 | Leva® PX Link Assembly |
10840642108002 | Leva® PX Link Assembly |
10840642107999 | Leva® PX Inserter Assembly |
10840642107982 | Leva® PX Link Assembly |
10840642107975 | PX Purple Link Assembly |
10840642106770 | Expandable Implant 22mm x 10mm x 14mm 10 Degree Lordotic |
10840642106763 | Expandable Implant 22mm x 10mm x 13mm 10 Degree Lordotic |
10840642106756 | Expandable Implant 22mm x 10mm x 12mm 10 Degree Lordotic |
10840642102659 | Expandable Implant 25mm x 10mm x 15mm 10 Degree Lordotic |
10840642102642 | Expandable Implant 25mm x 10mm x 14mm 10 Degree Lordotic |
10840642102635 | Expandable Implant 25mm x 10mm x 13mm 10 Degree Lordotic |
10840642102628 | Expandable Implant 25mm x 10mm x 12mm 10 Degree Lordotic |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() LEVA 97898990 not registered Live/Pending |
Axena Health, Inc. 2023-04-20 |
![]() LEVA 97868863 not registered Live/Pending |
Makabe, Tyler T 2023-04-01 |
![]() LEVA 97278880 not registered Live/Pending |
Renovia Inc. 2022-02-22 |
![]() LEVA 97278844 not registered Live/Pending |
Renovia Inc. 2022-02-22 |
![]() LEVA 97278819 not registered Live/Pending |
Renovia Inc. 2022-02-22 |
![]() LEVA 90588009 not registered Live/Pending |
Fawcett, Katherine A 2021-03-18 |
![]() LEVA 87642018 not registered Live/Pending |
LevaData, Inc. 2017-10-11 |
![]() LEVA 87469324 5400130 Live/Registered |
Vinex Slavyantsi AD 2017-05-31 |
![]() LEVA 87469324 5400130 Live/Registered |
Giertz Vinimport AB 2017-05-31 |
![]() LEVA 86136186 4841918 Live/Registered |
Spine Wave, Inc. 2013-12-05 |
![]() LEVA 86054368 5036873 Live/Registered |
Remendium Labs LLC 2013-09-03 |
![]() LEVA 86054360 5036872 Live/Registered |
Remendium Labs LLC 2013-09-03 |