HAtetracell™-C
GUDID M71165161805081
HAtetracell-C, 16L x 18W x 5H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
Metallic spinal interbody fusion cage| Primary Device ID | M71165161805081 |
| NIH Device Record Key | 3e1a3159-0231-4c8b-8aad-626803907d9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HAtetracell™-C |
| Version Model Number | 65-16180508 |
| 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 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com |
Device Dimensions
| Length | 16 Millimeter |
| Height | 5 Millimeter |
| Angle | 8 degree |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 5 Millimeter |
| Angle | 8 degree |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 5 Millimeter |
| Angle | 8 degree |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 5 Millimeter |
| Angle | 8 degree |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 5 Millimeter |
| Angle | 8 degree |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 5 Millimeter |
| Angle | 8 degree |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 5 Millimeter |
| Angle | 8 degree |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 5 Millimeter |
| Angle | 8 degree |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 5 Millimeter |
| Angle | 8 degree |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 5 Millimeter |
| Angle | 8 degree |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 5 Millimeter |
| Angle | 8 degree |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 5 Millimeter |
| Angle | 8 degree |
| Width | 18 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M71165161805080 [Primary] |
| HIBCC | M71165161805081 [Package] Contains: M71165161805080 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 | 2024-08-08 |
| 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 |
Trademark Results [HAtetracell]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HATETRACELL 97365136 not registered Live/Pending |
Innovasis, Inc. 2022-04-15 |
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