CxHA®, HAcancellous, HAtetracell
GUDID M711LS456300
TRIAL, 15L x 17W x 5-6H x 8°, SST
Innovasis, Inc.
Spinal implant trial| Primary Device ID | M711LS456300 |
| NIH Device Record Key | cb08d909-b8bb-47a2-ac14-6db8c0206817 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CxHA®, HAcancellous, HAtetracell |
| Version Model Number | LS-456-30 |
| 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 |
| 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 | |
| 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 | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
| Length | 15 Millimeter |
| Width | 17 Millimeter |
| Height | 5 Millimeter |
| Height | 6 Millimeter |
| Angle | 8 degree |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711LS456300 [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 |
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
[M711LS456300]
Moist Heat or Steam Sterilization
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 [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° |
| M711LS456320 | TRIAL, 16L x 19W x 5-6H x 8°, SST |
| M711LS456310 | TRIAL, 16L x 18W x 5-6H x 8°, SST |
| M711LS456300 | TRIAL, 15L x 17W x 5-6H x 8°, SST |
| M711LS456290 | TRIAL, 14L x 17W x 5-6H x 8°, SST |
| M711LS456280 | TRIAL, 14L x 16W x 5-6H x 8°, SST |
| M711LS456270 | TRIAL, 13L x 15W x 5-6H x 8°, SST |
| M711LS456260 | TRIAL, 12L x 15W x 5-6H x 8°, SST |
| M711LS456250 | TRIAL, 12L x 14W x 5-6H x 8°, SST |
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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