HAtetracell™-C

GUDID M71165121406081

HAtetracell-C, 12L x 14W x 6H x 8°, Ti 6Al 4V (ELI), HA

Innovasis, Inc.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

Primary Device ID	M71165121406081
NIH Device Record Key	0b1e455e-766d-431f-bbdc-d42bc2109910
Commercial Distribution Status	In Commercial Distribution
Brand Name	HAtetracell™-C
Version Model Number	65-12140608
Company DUNS	156567492
Company Name	Innovasis, Inc.
Device Count	1
DM Exempt	false
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	false
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
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	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter
Length	12 Millimeter
Height	6 Millimeter
Angle	8 degree
Width	14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M71165121406080 [Primary]
HIBCC	M71165121406081 [Package] Contains: M71165121406080 Package: Carton [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K231899

FDA Product Code

ODP	Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-06-10
Device Publish Date	2024-05-31

On-Brand Devices [HAtetracell™-C]

M71165151710121	HAtetracell-C, 15L x 17W x 10H x 12°, Ti 6Al 4V (ELI), HA
M71165151710081	HAtetracell-C, 15L x 17W x 10H x 8°, Ti 6Al 4V (ELI), HA
M71165151709121	HAtetracell-C, 15L x 17W x 9H x 12°, Ti 6Al 4V (ELI), HA
M71165151709081	HAtetracell-C, 15L x 17W x 9H x 8°, Ti 6Al 4V (ELI), HA
M71165151708121	HAtetracell-C, 15L x 17W x 8H x 12°, Ti 6Al 4V (ELI), HA
M71165151708081	HAtetracell-C, 15L x 17W x 8H x 8°, Ti 6Al 4V (ELI), HA
M71165151707121	HAtetracell-C, 15L x 17W x 7H x 12°, Ti 6Al 4V (ELI), HA
M71165151707081	HAtetracell-C, 15L x 17W x 7H x 8°, Ti 6Al 4V (ELI), HA
M71165151706121	HAtetracell-C, 15L x 17W x 6H x 12°, Ti 6Al 4V (ELI), HA
M71165151706081	HAtetracell-C, 15L x 17W x 6H x 8°, Ti 6Al 4V (ELI), HA
M71165151705081	HAtetracell-C, 15L x 17W x 5H x 8°, Ti 6Al 4V (ELI), HA
M71165141712121	HAtetracell-C, 14L x 17W x 12H x 12°, Ti 6Al 4V (ELI), HA
M71165141712081	HAtetracell-C, 14L x 17W x 12H x 8°, Ti 6Al 4V (ELI), HA
M71165141711121	HAtetracell-C, 14L x 17W x 11H x 12°, Ti 6Al 4V (ELI), HA
M71165141711081	HAtetracell-C, 14L x 17W x 11H x 8°, Ti 6Al 4V (ELI), HA
M71165141710121	HAtetracell-C, 14L x 17W x 10H x 12°, Ti 6Al 4V (ELI), HA
M71165141710081	HAtetracell-C, 14L x 17W x 10H x 8°,Ti 6Al 4V (ELI), HA
M71165141709121	HAtetracell-C, 14L x 17W x 9H x 12°, Ti 6Al 4V (ELI), HA
M71165141709081	HAtetracell-C, 14L x 17W x 9H x 8°, Ti 6Al 4V (ELI), HA
M71165141708121	HAtetracell-C, 14L x 17W x 8H x 12°, Ti 6Al 4V (ELI), HA
M71165141708081	HAtetracell-C, 14L x 17W x 8H x 8°, Ti 6Al 4V (ELI), HA
M71165141707121	HAtetracell-C, 14L x 17W x 7H x 12°, Ti 6Al 4V (ELI), HA
M71165141707081	HAtetracell-C, 14L x 17W x 7H x 8°, Ti 6Al 4V (ELI), HA
M71165141706121	HAtetracell-C, 14L x 17W x 6H x 12°, Ti 6Al 4V (ELI), HA
M71165141706081	HAtetracell-C, 14L x 17W x 6H x 8°, Ti 6Al 4V (ELI), HA
M71165141705081	HAtetracell-C, 14L x 17W x 5H x 8°, Ti 6Al 4V (ELI), HA
M71165141612121	HAtetracell-C, 14L x 16W x 12H x 12°, Ti 6Al 4V (ELI), HA
M71165141612081	HAtetracell-C, 14L x 16W x 12H x 8°, Ti 6Al 4V (ELI), HA
M71165141611121	HAtetracell-C, 14L x 16W x 11H x 12°, Ti 6Al 4V (ELI), HA
M71165141611081	HAtetracell-C, 14L x 16W x 11H x 8°, Ti 6Al 4V (ELI), HA
M71165141610121	HAtetracell-C, 14L x 16W x 10H x 12°, Ti 6Al 4V (ELI), HA
M71165141610081	HAtetracell-C, 14L x 16W x 10H x 8°, Ti 6Al 4V (ELI), HA
M71165141609121	HAtetracell-C, 14L x 16W x 9H x 12°, Ti 6Al 4V (ELI), HA
M71165141609081	HAtetracell-C, 14L x 16W x 9H x 8°, Ti 6Al 4V (ELI), HA
M71165141608121	HAtetracell-C, 14L x 16W x 8H x 12°, Ti 6Al 4V (ELI), HA
M71165141608081	HAtetracell-C, 14L x 16W x 8H x 8°, Ti 6Al 4V (ELI), HA
M71165141607121	HAtetracell-C, 14L x 16W x 7H x 12°, Ti 6Al 4V (ELI), HA
M71165141607081	HAtetracell-C, 14L x 16W x 7H x 8°, Ti 6Al 4V (ELI), HA
M71165141606121	HAtetracell-C, 14L x 16W x 6H x 12°, Ti 6Al 4V (ELI), HA
M71165141606081	HAtetracell-C, 14L x 16W x 6H x 8°, Ti 6Al 4V (ELI), HA
M71165141605081	HAtetracell-C, 14L x 16W x 5H x 8°, Ti 6Al 4V (ELI), HA
M71165131512121	HAtetracell-C, 13L x 15W x 12H x 12°, Ti 6Al 4V (ELI), HA
M71165131512081	HAtetracell-C, 13L x 15W x 12H x 8°, Ti 6Al 4V (ELI), HA
M71165131511121	HAtetracell-C, 13L x 15W x 11H x 12°, Ti 6Al 4V (ELI), HA
M71165131511081	HAtetracell-C, 13L x 15W x 11H x 8°, Ti 6Al 4V (ELI), HA
M71165131510121	HAtetracell-C, 13L x 15W x 10H x 12°, Ti 6Al 4V (ELI), HA
M71165131510081	HAtetracell-C, 13L x 15W x 10H x 8°, Ti 6Al 4V (ELI), HA
M71165131509121	HAtetracell-C, 13L x 15W x 9H x 12°, Ti 6Al 4V (ELI), HA
M71165131509081	HAtetracell-C, 13L x 15W x 9H x 8°, Ti 6Al 4V (ELI), HA
M71165131508121	HAtetracell-C, 13L x 15W x 8H x 12°, Ti 6Al 4V (ELI), HA

Trademark Results [HAtetracell]

Mark Image Registration \| Serial	Company Trademark Application Date
HATETRACELL 97365136 not registered Live/Pending	Innovasis, Inc. 2022-04-15