CxHA®, HAcancellous, HAtetracell LS-456-16
GUDID M711LS456160
TRIAL, 15L x 17W x 7-8H x 8°
Innovasis, Inc.
Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial| Primary Device ID | M711LS456160 |
| NIH Device Record Key | d8e34ada-3697-4f21-9d83-cd4e35f263af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CxHA®, HAcancellous, HAtetracell |
| Version Model Number | LS-456-16 |
| Catalog Number | LS-456-16 |
| 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 |
| 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 | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com |
Device Dimensions
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 8 Millimeter |
| Height | 7 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 8 Millimeter |
| Height | 7 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 8 Millimeter |
| Height | 7 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 8 Millimeter |
| Height | 7 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 8 Millimeter |
| Height | 7 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 8 Millimeter |
| Height | 7 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 8 Millimeter |
| Height | 7 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 8 Millimeter |
| Height | 7 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 8 Millimeter |
| Height | 7 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 8 Millimeter |
| Height | 7 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 8 Millimeter |
| Height | 7 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 8 Millimeter |
| Height | 7 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 8 Millimeter |
| Height | 7 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 8 Millimeter |
| Height | 7 Millimeter |
| Angle | 8 degree |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711LS456160 [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 |
[M711LS456160]
Moist Heat or Steam Sterilization
[M711LS456160]
Moist Heat or Steam Sterilization
[M711LS456160]
Moist Heat or Steam Sterilization
[M711LS456160]
Moist Heat or Steam Sterilization
[M711LS456160]
Moist Heat or Steam Sterilization
[M711LS456160]
Moist Heat or Steam Sterilization
[M711LS456160]
Moist Heat or Steam Sterilization
[M711LS456160]
Moist Heat or Steam Sterilization
[M711LS456160]
Moist Heat or Steam Sterilization
[M711LS456160]
Moist Heat or Steam Sterilization
[M711LS456160]
Moist Heat or Steam Sterilization
[M711LS456160]
Moist Heat or Steam Sterilization
[M711LS456160]
Moist Heat or Steam Sterilization
[M711LS456160]
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° |
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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