True Position® Spacer System 1208-01-3013

GUDID 10840642107609

Implant, Lordotic, 30 (L) x 13 (H) mm, 7°

Spine Wave, Inc.

Metal-polymer composite spinal interbody fusion cage
Primary Device ID10840642107609
NIH Device Record Key375a761b-4339-4f42-9437-235516ce53ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrue Position® Spacer System
Version Model Number1208-01-3013
Catalog Number1208-01-3013
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 Datefalse
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

Height13 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110840642107609 [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

[10840642107609]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-24
Device Publish Date2016-09-24

On-Brand Devices [True Position® Spacer System]

10840642107890XL Implant Inserter Assembly
10840642107883Implant Inserter
10840642107722Implant, 36 (L) x 7.5 (H) mm
10840642107715Implant, 30 (L) x 7.5 (H) mm
10840642107708Implant, 27 (L) x 7.5 (H) mm
10840642107692Implant, Lordotic, 36 (L) x 15 (H) mm, 7°
10840642107685Implant, Lordotic, 36 (L) x 14 (H) mm, 7°
10840642107678Implant, Lordotic, 36 (L) x 13 (H) mm, 7°
10840642107661Implant, Lordotic, 36 (L) x 12 (H) mm, 7°
10840642107654Implant, Lordotic, 36 (L) x 11 (H) mm, 7°
10840642107647Implant, Lordotic, 36 (L) x 10 (H) mm, 7°
10840642107630Implant, Lordotic, 36 (L) x 9 (H) mm, 7°
10840642107623Implant, Lordotic, 30 (L) x 15 (H) mm, 7°
10840642107616Implant, Lordotic, 30 (L) x 14 (H) mm, 7°
10840642107609Implant, Lordotic, 30 (L) x 13 (H) mm, 7°
10840642107593Implant, Lordotic, 30 (L) x 12 (H) mm, 7°
10840642107586Implant, Lordotic, 30 (L) x 11 (H) mm, 7°
10840642107579Implant, Lordotic, 30 (L) x 10 (H) mm, 7°
10840642107562Implant, Lordotic, 30 (L) x 9 (H) mm, 7°
10840642107555Implant, Lordotic, 27 (L) x 15 (H) mm, 7°
10840642107548Implant, Lordotic, 27 (L) x 14 (H) mm, 7°
10840642107531Implant, Lordotic, 27 (L) x 13 (H) mm, 7°
10840642107524Implant, Lordotic, 27 (L) x 12 (H) mm, 7°
10840642107517Implant, Lordotic, 27 (L) x 11 (H) mm, 7°
10840642107500Implant, Lordotic, 27 (L) x 10 (H) mm, 7°
10840642107494Implant, Lordotic, 27 (L) x 9 (H) mm, 7°

Trademark Results [True Position]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRUE POSITION
TRUE POSITION
86258168 4652227 Live/Registered
Dayton Progress Corporation
2014-04-21
TRUE POSITION
TRUE POSITION
77909781 3948826 Live/Registered
SPINE WAVE, INC.
2010-01-12
TRUE POSITION
TRUE POSITION
75336437 not registered Dead/Abandoned
EXSYS Tool, Inc.
1997-08-05
TRUE POSITION
TRUE POSITION
74638035 1946974 Live/Registered
Modern Builders Supply, Inc.
1995-02-22
TRUE POSITION
TRUE POSITION
74604318 not registered Dead/Abandoned
Associated RT, Inc.
1994-11-29
TRUE POSITION
TRUE POSITION
73435836 1326563 Live/Registered
Dayton Progress Corporation
1983-07-22

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