Leva™ Spacer System 11-7308

GUDID 10840642100389

Fixed Implant 22mm x 10mm x 8mm

Spine Wave, Inc.

Metallic spinal interbody fusion cage
Primary Device ID10840642100389
NIH Device Record Key8ba1c1fd-e05d-4eab-827f-ef9b001b2951
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeva™ Spacer System
Version Model Number11-7308
Catalog Number11-7308
Company DUNS067789763
Company NameSpine Wave, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone203-944-9494
EmailGUDID@spinewave.com

Device Dimensions

Length22 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110840642100389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2015-10-24

On-Brand Devices [Leva™ Spacer System]

10840642100495Expandable Implant 22mm x 10mm x 14mm
10840642100488Expandable Implant 22mm x 10mm x 13mm
10840642100471Expandable Implant 22mm x 10mm x 12mm
10840642100464Expandable Implant 22mm x 10mm x 11mm
10840642100457Expandable Implant 22mm x 10mm x 10mm
10840642100440Fixed Implant 22mm x 10mm x 14mm
10840642100433Fixed Implant 22mm x 10mm x 13mm
10840642100426Fixed Implant 22mm x 10mm x 12mm
10840642100419Fixed Implant 22mm x 10mm x 11mm
10840642100402Fixed Implant 22mm x 10mm x 10mm
10840642100396Fixed Implant 22mm x 10mm x 9mm
10840642100389Fixed Implant 22mm x 10mm x 8mm
10840642100372Fixed Implant 22mm x 10mm x 7mm
10840642100358Fixed Implant 25mm x 10mm x 14mm
10840642100341Fixed Implant 25mm x 10mm x 13mm
10840642100334Fixed Implant 25mm x 10mm x 12mm
10840642100327Fixed Implant 25mm x 10mm x 11mm
10840642100310Fixed Implant 25mm x 10mm x 10mm
10840642100099Fixed Implant 25mm x 10mm x 9mm
10840642100082Fixed Implant 25mm x 10mm x 8mm
10840642100075Fixed Implant 25mm x 10mm x 7mm
10840642100068Expandable Implant 25mm x 10mm x 15mm
10840642100051Expandable Implant 25mm x 10mm x 14mm
10840642100044Expandable Implant 25mm x 10mm x 13mm
10840642100037Expandable Implant 25mm x 10mm x 12mm
10840642100020Expandable Implant 25mm x 10mm x 11mm
10840642100013Expandable Implant 25mm x 10mm x 10mm

Trademark Results [Leva]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LEVA
LEVA
97898990 not registered Live/Pending
Axena Health, Inc.
2023-04-20
LEVA
LEVA
97868863 not registered Live/Pending
Makabe, Tyler T
2023-04-01
LEVA
LEVA
97278880 not registered Live/Pending
Renovia Inc.
2022-02-22
LEVA
LEVA
97278844 not registered Live/Pending
Renovia Inc.
2022-02-22
LEVA
LEVA
97278819 not registered Live/Pending
Renovia Inc.
2022-02-22
LEVA
LEVA
90588009 not registered Live/Pending
Fawcett, Katherine A
2021-03-18
LEVA
LEVA
87642018 not registered Live/Pending
LevaData, Inc.
2017-10-11
LEVA
LEVA
87469324 5400130 Live/Registered
Vinex Slavyantsi AD
2017-05-31
LEVA
LEVA
87469324 5400130 Live/Registered
Giertz Vinimport AB
2017-05-31
LEVA
LEVA
86136186 4841918 Live/Registered
Spine Wave, Inc.
2013-12-05
LEVA
LEVA
86054368 5036873 Live/Registered
Remendium Labs LLC
2013-09-03
LEVA
LEVA
86054360 5036872 Live/Registered
Remendium Labs LLC
2013-09-03

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