HAtetracell™-C

GUDID M711LS758010

Trial, 12L x 14W x 5-6H x 12°, SST

Innovasis, Inc.

Spinal implant trial

• Primary Device ID: M711LS758010
• NIH Device Record Key: d0373c02-adfe-4a8e-adef-70c244423779
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAtetracell™-C
• Version Model Number: LS-758-01
• 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: 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

Device Dimensions

• Length: 12 Millimeter
• Width: 14 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Length: 12 Millimeter
• Width: 14 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Length: 12 Millimeter
• Width: 14 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Length: 12 Millimeter
• Width: 14 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Length: 12 Millimeter
• Width: 14 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Length: 12 Millimeter
• Width: 14 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Length: 12 Millimeter
• Width: 14 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Length: 12 Millimeter
• Width: 14 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Length: 12 Millimeter
• Width: 14 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Length: 12 Millimeter
• Width: 14 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Length: 12 Millimeter
• Width: 14 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Length: 12 Millimeter
• Width: 14 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711LS758010 [Primary]

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: true
• Device Is Sterile: false

[M711LS758010]

Moist Heat or Steam Sterilization

[M711LS758010]

Moist Heat or Steam Sterilization

[M711LS758010]

Moist Heat or Steam Sterilization

[M711LS758010]

Moist Heat or Steam Sterilization

[M711LS758010]

Moist Heat or Steam Sterilization

[M711LS758010]

Moist Heat or Steam Sterilization

[M711LS758010]

Moist Heat or Steam Sterilization

[M711LS758010]

Moist Heat or Steam Sterilization

[M711LS758010]

Moist Heat or Steam Sterilization

[M711LS758010]

Moist Heat or Steam Sterilization

[M711LS758010]

Moist Heat or Steam Sterilization

[M711LS758010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-08
• Device Publish Date: 2024-07-31

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