HAtetracell™-C

GUDID M71165161810121

HAtetracell-C, 16L x 18W x 10H x 12°, Ti 6Al 4V (ELI), HA

Innovasis, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: M71165161810121
• NIH Device Record Key: d68acf98-d8de-461b-9323-9f364d8969cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAtetracell™-C
• Version Model Number: 65-16181012
• 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: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter
• Length: 16 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Width: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M71165161810120 [Primary]
HIBCC	M71165161810121 [Package]; Contains: M71165161810120; 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: 2024-09-09
• Device Publish Date: 2024-08-31

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