ANAX™ 5.5 SPINAL SYSTEM

GUDID 08800015972154

Innosys Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	08800015972154
NIH Device Record Key	04da41c4-a83c-4767-81bb-5a62ef8ce387
Commercial Distribution Status	In Commercial Distribution
Brand Name	ANAX™ 5.5 SPINAL SYSTEM
Version Model Number	SR5150CS
Company DUNS	688811082
Company Name	Innosys Co., Ltd.
Device Count	1
DM Exempt	true
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	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800015972154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K143417

FDA Product Code

MNH	Orthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

[08800015972154]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2023-06-19
Device Publish Date	2018-01-24

On-Brand Devices [ANAX™ 5.5 SPINAL SYSTEM]

08800037544919	SF0360
08800037544902	SF0350
08800037520968	SFM0220
08800037520920	SFDA8095LR
08800037520913	SFDA8090LR
08800037520906	SFDA8085LR
08800037520890	SFDA8080LR
08800037520883	SFDA8075LR
08800037520876	SFDA8070LR
08800037520869	SFDA8065LR
08800037520852	SFDA8060LR
08800037520845	SFDA8055LR
08800037520838	SFDA8050LR
08800037520821	SFDA8045LR
08800037520814	SFDA8040LR
08800037520807	SFDA8035LR
08800037520791	SFDA8030LR
08800037520784	SFDA7595LR
08800037520777	SFDA7590LR
08800037520760	SFDA7585LR
08800037520753	SFDA7580LR
08800037520746	SFDA7575LR
08800037520739	SFDA7570LR
08800037520722	SFDA7565LR
08800037520715	SFDA7560LR
08800037520708	SFDA7555LR
08800037520692	SFDA7550LR
08800037520685	SFDA7545LR
08800037520678	SFDA7540LR
08800037520661	SFDA7535LR
08800037520654	SFDA7530LR
08800037520647	SFDA7080LR
08800037520630	SFDA7075LR
08800037520623	SFDA7070LR
08800037520616	SFDA7065LR
08800037520609	SFDA7060LR
08800037520593	SFDA7055LR
08800037520586	SFDA7050LR
08800037520579	SFDA7045LR
08800037520562	SFDA7040LR
08800037520555	SFDA7035LR
08800037520548	SFDA7030LR
08800037520531	SFDA6580LR
08800037520524	SFDA6575LR
08800037520517	SFDA6570LR
08800037520500	SFDA6565LR
08800037520494	SFDA6560LR
08800037520487	SFDA6555LR
08800037520470	SFDA6550LR
08800037520463	SFDA6545LR

Trademark Results [ANAX]

Mark Image Registration \| Serial	Company Trademark Application Date
ANAX 97056657 not registered Live/Pending	Anaxdent North America LLC 2021-10-01
ANAX 88571862 not registered Live/Pending	Corbett & Brown Inc. 2019-08-08
ANAX 87276522 5237188 Live/Registered	Microtech Knives, Inc. 2016-12-21
ANAX 86459418 4772772 Live/Registered	ANAX Business Technologies, LLC 2014-11-19
ANAX 79024628 3275432 Dead/Cancelled	DOMAINE GEROVASSILIOU S.A. 2006-05-22
ANAX 77205255 not registered Dead/Abandoned	Archon Capital Management LLC 2007-06-13

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