Leva® Spacer System 10-7242.2

GUDID 10840642125351

PX White Link Assembly, Tabbed

Spine Wave, Inc.

Metallic spinal interbody fusion cage
Primary Device ID10840642125351
NIH Device Record Key3c4fe800-8f45-408e-beff-9b1a91875326
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeva® Spacer System
Version Model Number10-7242.2
Catalog Number10-7242.2
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 Identifiers

Device Issuing AgencyDevice ID
GS110840642125351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10840642125351]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2018-01-08

On-Brand Devices [Leva® Spacer System]

10840642125399PX Brown Link Assembly, Tabbed
10840642125382PX Purple Link Assembly, Tabbed
10840642125375PX Blue Link Assembly, Tabbed
10840642125368PX Green Link Assembly, Tabbed
10840642125351PX White Link Assembly, Tabbed
10840642117370PX White Inserter Assembly
10840642117363PX Green/Blue Inserter Assembly
10840642117356PX Purple/Brown Inserter Assembly
10840642108095Leva® PX Inner Shaft Assembly 22mm 7-8-9mm
10840642108088Leva® PX Outer Handle Assembly 22mm X 7-8-9mm
10840642108071Leva® PX Expander Assy., 7, 8, 9mm
10840642108064Leva® PX Inserter, 25 x 7, 8, 9mm
10840642108057Leva® PX Link Assembly, Blue
10840642108040Leva® PX Link Assembly, Bronze
10840642108033Leva® PX Link Assembly
10840642108026Leva® PX Inserter Assembly
10840642108019Leva® PX Link Assembly
10840642108002Leva® PX Link Assembly
10840642107999Leva® PX Inserter Assembly
10840642107982Leva® PX Link Assembly
10840642107975PX Purple Link Assembly
10840642106770Expandable Implant 22mm x 10mm x 14mm 10 Degree Lordotic
10840642106763Expandable Implant 22mm x 10mm x 13mm 10 Degree Lordotic
10840642106756Expandable Implant 22mm x 10mm x 12mm 10 Degree Lordotic
10840642102659Expandable Implant 25mm x 10mm x 15mm 10 Degree Lordotic
10840642102642Expandable Implant 25mm x 10mm x 14mm 10 Degree Lordotic
10840642102635Expandable Implant 25mm x 10mm x 13mm 10 Degree Lordotic
10840642102628Expandable Implant 25mm x 10mm x 12mm 10 Degree Lordotic

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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