Primary Device ID | 10840642100495 |
NIH Device Record Key | eb9f5b5e-bb18-46f2-8549-92beaee11844 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Leva™ Spacer System |
Version Model Number | 11-7214 |
Catalog Number | 11-7214 |
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 |
Length | 22 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10840642100495 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2015-10-24 |
10840642100495 | Expandable Implant 22mm x 10mm x 14mm |
10840642100488 | Expandable Implant 22mm x 10mm x 13mm |
10840642100471 | Expandable Implant 22mm x 10mm x 12mm |
10840642100464 | Expandable Implant 22mm x 10mm x 11mm |
10840642100457 | Expandable Implant 22mm x 10mm x 10mm |
10840642100440 | Fixed Implant 22mm x 10mm x 14mm |
10840642100433 | Fixed Implant 22mm x 10mm x 13mm |
10840642100426 | Fixed Implant 22mm x 10mm x 12mm |
10840642100419 | Fixed Implant 22mm x 10mm x 11mm |
10840642100402 | Fixed Implant 22mm x 10mm x 10mm |
10840642100396 | Fixed Implant 22mm x 10mm x 9mm |
10840642100389 | Fixed Implant 22mm x 10mm x 8mm |
10840642100372 | Fixed Implant 22mm x 10mm x 7mm |
10840642100358 | Fixed Implant 25mm x 10mm x 14mm |
10840642100341 | Fixed Implant 25mm x 10mm x 13mm |
10840642100334 | Fixed Implant 25mm x 10mm x 12mm |
10840642100327 | Fixed Implant 25mm x 10mm x 11mm |
10840642100310 | Fixed Implant 25mm x 10mm x 10mm |
10840642100099 | Fixed Implant 25mm x 10mm x 9mm |
10840642100082 | Fixed Implant 25mm x 10mm x 8mm |
10840642100075 | Fixed Implant 25mm x 10mm x 7mm |
10840642100068 | Expandable Implant 25mm x 10mm x 15mm |
10840642100051 | Expandable Implant 25mm x 10mm x 14mm |
10840642100044 | Expandable Implant 25mm x 10mm x 13mm |
10840642100037 | Expandable Implant 25mm x 10mm x 12mm |
10840642100020 | Expandable Implant 25mm x 10mm x 11mm |
10840642100013 | Expandable Implant 25mm x 10mm x 10mm |
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 |