CxHA®, HAcancellous, HAtetracell LS-456-21

GUDID M711LS456210

TRIAL, 16L x 18W x 11-12H x 8°

Innovasis, Inc.

Spinal implant trial

Primary Device ID	M711LS456210
NIH Device Record Key	841cad29-4a0f-4c65-b3d3-1582d2515741
Commercial Distribution Status	In Commercial Distribution
Brand Name	CxHA®, HAcancellous, HAtetracell
Version Model Number	LS-456-21
Catalog Number	LS-456-21
Company DUNS	156567492
Company Name	Innovasis, Inc.
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	false
Lot Batch	false
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

Customer Support Contacts

Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com

Device Dimensions

Length	16 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Height	11 Millimeter
Angle	8 degree
Length	16 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Height	11 Millimeter
Angle	8 degree
Length	16 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Height	11 Millimeter
Angle	8 degree
Length	16 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Height	11 Millimeter
Angle	8 degree
Length	16 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Height	11 Millimeter
Angle	8 degree
Length	16 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Height	11 Millimeter
Angle	8 degree
Length	16 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Height	11 Millimeter
Angle	8 degree
Length	16 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Height	11 Millimeter
Angle	8 degree
Length	16 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Height	11 Millimeter
Angle	8 degree
Length	16 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Height	11 Millimeter
Angle	8 degree
Length	16 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Height	11 Millimeter
Angle	8 degree
Length	16 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Height	11 Millimeter
Angle	8 degree
Length	16 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Height	11 Millimeter
Angle	8 degree
Length	16 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Height	11 Millimeter
Angle	8 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711LS456210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K181115

FDA Product Code

ODP	Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[M711LS456210]

Moist Heat or Steam Sterilization

[M711LS456210]

Moist Heat or Steam Sterilization

[M711LS456210]

Moist Heat or Steam Sterilization

[M711LS456210]

Moist Heat or Steam Sterilization

[M711LS456210]

Moist Heat or Steam Sterilization

[M711LS456210]

Moist Heat or Steam Sterilization

[M711LS456210]

Moist Heat or Steam Sterilization

[M711LS456210]

Moist Heat or Steam Sterilization

[M711LS456210]

Moist Heat or Steam Sterilization

[M711LS456210]

Moist Heat or Steam Sterilization

[M711LS456210]

Moist Heat or Steam Sterilization

[M711LS456210]

Moist Heat or Steam Sterilization

[M711LS456210]

Moist Heat or Steam Sterilization

[M711LS456210]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2023-10-31
Device Publish Date	2018-09-30

On-Brand Devices [CxHA®, HAcancellous, HAtetracell]

M711LS456240	TRIAL, 16L x 19W x 11-12H x 8°
M711LS456230	TRIAL, 16L x 19W x 9-10H x 8°
M711LS456220	TRIAL, 16L x 19W x 7-8H x 8°
M711LS456210	TRIAL, 16L x 18W x 11-12H x 8°
M711LS456200	TRIAL, 16L x 18W x 9-10H x 8°
M711LS456190	TRIAL, 16L x 18W x 7-8H x 8°
M711LS456180	TRIAL, 15L x 17W x 11-12H x 8°
M711LS456170	TRIAL, 15L x 17W x 9-10H x 8°
M711LS456160	TRIAL, 15L x 17W x 7-8H x 8°
M711LS456150	TRIAL, 14L x 17W x 11-12H x 8°
M711LS456140	TRIAL, 14L x 17W x 9-10H x 8°
M711LS456130	TRIAL, 14L x 17W x 7-8H x 8°
M711LS456120	TRIAL, 14L x 16W x 11-12H x 8°
M711LS456110	TRIAL, 14L x 16W x 9-10H x 8°
M711LS456100	TRIAL, 14L x 16W x 7-8H x 8°
M711LS456090	TRIAL, 13L x 15W x 11-12H x 8°
M711LS456080	TRIAL, 13L x 15W x 9-10H x 8°
M711LS456070	TRIAL, 13L x 15W x 7-8H x 8°
M711LS456060	TRIAL, 12L x 15W x 11-12H x 8°
M711LS456050	TRIAL, 12L x 15W x 9-10H x 8°
M711LS456040	TRIAL, 12L x 15W x 7-8H x 8°
M711LS456030	TRIAL, 12L x 14W x 11-12H x 8°
M711LS456020	TRIAL, 12L x 14W x 9-10H x 8°
M711LS456010	TRIAL, 12L x 14W x 7-8H x 8°
M711LS456320	TRIAL, 16L x 19W x 5-6H x 8°, SST
M711LS456310	TRIAL, 16L x 18W x 5-6H x 8°, SST
M711LS456300	TRIAL, 15L x 17W x 5-6H x 8°, SST
M711LS456290	TRIAL, 14L x 17W x 5-6H x 8°, SST
M711LS456280	TRIAL, 14L x 16W x 5-6H x 8°, SST
M711LS456270	TRIAL, 13L x 15W x 5-6H x 8°, SST
M711LS456260	TRIAL, 12L x 15W x 5-6H x 8°, SST
M711LS456250	TRIAL, 12L x 14W x 5-6H x 8°, SST

Trademark Results [CxHA]

Mark Image Registration \| Serial	Company Trademark Application Date
CXHA 87872961 5624262 Live/Registered	Innovasis, Inc. 2018-04-11

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