HAcancellous™ PEEK-C
GUDID M711591214081
HAcancellous PEEK-C, 12L x 14W x 8H x 8°, HA PEEK, Ta,
Innovasis, Inc.
Polymeric spinal interbody fusion cage| Primary Device ID | M711591214081 |
| NIH Device Record Key | 4528d6eb-90ad-4475-a365-5e94652388d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HAcancellous™ PEEK-C |
| Version Model Number | 59-121408 |
| 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 | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com |
Device Dimensions
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 8 Millimeter |
| Angle | 8 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 8 Millimeter |
| Angle | 8 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 8 Millimeter |
| Angle | 8 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 8 Millimeter |
| Angle | 8 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 8 Millimeter |
| Angle | 8 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 8 Millimeter |
| Angle | 8 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 8 Millimeter |
| Angle | 8 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 8 Millimeter |
| Angle | 8 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 8 Millimeter |
| Angle | 8 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 8 Millimeter |
| Angle | 8 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 8 Millimeter |
| Angle | 8 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 8 Millimeter |
| Angle | 8 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 8 Millimeter |
| Angle | 8 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 8 Millimeter |
| Angle | 8 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 8 Millimeter |
| Angle | 8 degree |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711591214080 [Primary] |
| HIBCC | M711591214081 [Package] Contains: M711591214080 Package: Carton [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220875
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 | 2023-09-08 |
| Device Publish Date | 2023-08-31 |
On-Brand Devices [HAcancellous™ PEEK-C]
| M711591215121 | HAcancellous PEEK-C, 12L x 15W x 12H x 8°, HA PEEK, Ta |
| M711591215111 | HAcancellous PEEK-C, 12L x 15W x 11H x 8°, HA PEEK, Ta |
| M711591215101 | HAcancellous PEEK-C, 12L x 15W x 10H x 8°, HA PEEK, Ta |
| M711591215091 | HAcancellous PEEK-C, 12L x 15W x 9H x 8°, HA PEEK, Ta |
| M711591215081 | HAcancellous PEEK-C, 12L x 15W x 8H x 8° |
| M711591215071 | HAcancellous PEEK-C, 12L x 15W x 7H x 8°, HA PEEK, Ta |
| M711591215061 | HAcancellous PEEK-C, 12L x 15W x 6H x 8°, HA PEEK, Ta |
| M711591214121 | HAcancellous PEEK-C, 12L x 14W x 12H x 8°, HA PEEK, Ta |
| M711591214111 | HAcancellous PEEK-C, 12L x 14W x 11H x 8°, HA PEEK, Ta |
| M711591214101 | HAcancellous PEEK-C, 12L x 14W x 10H x 8°, HA PEEK, Ta |
| M711591214091 | HAcancellous PEEK-C, 12L x 14W x 9H x 8°, HA PEEK, Ta |
| M711591214081 | HAcancellous PEEK-C, 12L x 14W x 8H x 8°, HA PEEK, Ta, |
| M711591214071 | HAcancellous PEEK-C, 12L x 14W x 7H x 8°, HA PEEK, Ta |
| M711591214060 | HAcancellous PEEK-C, 12L x 14W x 6H x 8°, HA PEEK, Ta |
| M711591619111 | HAcancellous PEEK-C, 16L x 19W x 11H x 8°, HA PEEK, Ta |
| M711591619101 | HAcancellous PEEK-C, 16L x 19W x 10H x 8°, HA PEEK, Ta |
| M711591619091 | HAcancellous PEEK-C, 16L x 19W x 9H x 8°, HA PEEK, Ta |
| M711591619081 | HAcancellous PEEK-C, 16L x 19W x 8H x 8°°, HA PEEK, Ta |
| M711591619071 | HAcancellous PEEK-C, 16L x 19W x 7H x 8°, HA PEEK, Ta |
| M711591416071 | HAcancellous PEEK-C, 14L x 16W x 7H x 8°, HA PEEK, Ta |
| M711591416061 | HAcancellous PEEK-C, 14L x 16W x 6H x 8°, HA PEEK, Ta |
| M711591315111 | HAcancellous PEEK-C, 13L x 15W x 11H x 8°, HA PEEK, Ta |
| M711591315061 | HAcancellous PEEK-C, 13L x 15W x 6H x 8°, HA PEEK, Ta |
| M711591619061 | HAcancellous PEEK-C, 16L x 19W x 6H x 8°, HA PEEK, Ta |
| M711591618121 | HAcancellous PEEK-C, 16L x 18W x 12H x 8°, HA PEEK, Ta |
| M711591618111 | HAcancellous PEEK-C, 16L x 18W x 11H x 8°, HA PEEK, Ta |
| M711591618101 | HAcancellous PEEK-C, 16L x 18W x 10H x 8°, HA PEEK, Ta |
| M711591618091 | HAcancellous PEEK-C, 16L x 18W x 9H x 8°, HA PEEK, Ta |
| M711591618081 | HAcancellous PEEK-C, 16L x 18W x 8H x 8°, HA PEEK, Ta |
| M711591618071 | HAcancellous PEEK-C, 16L x 18W x 7H x 8°, HA PEEK, Ta |
| M711591618061 | HAcancellous PEEK-C, 16L x 18W x 6H x 8°, HA PEEK, Ta |
| M711591517121 | HAcancellous PEEK-C, 15L x 17W x 12H x 8°, HA PEEK, Ta |
| M711591517111 | HAcancellous PEEK-C, 15L x 17W x 11H x 8°, HA PEEK, Ta |
| M711591517101 | HAcancellous PEEK-C, 15L x 17W x 10H x 8°, HA PEEK, Ta |
| M711591517091 | HAcancellous PEEK-C, 15L x 17W x 9H x 8°, HA PEEK, Ta |
| M711591517081 | HAcancellous PEEK-C, 15L x 17W x 8H x 8°, HA PEEK, Ta |
| M711591517071 | HAcancellous PEEK-C, 15L x 17W x 7H x 8°, HA PEEK, Ta |
| M711591517061 | HAcancellous PEEK-C, 15L x 17W x 6H x 8°, HA PEEK, Ta |
| M711591417111 | HAcancellous PEEK-C, 14L x 17W x 11H x 8°, HA PEEK, Ta |
| M711591417101 | HAcancellous PEEK-C, 14L x 17W x 10H x 8°, HA PEEK, Ta |
| M711591417091 | HAcancellous PEEK-C, 14L x 17W x 9H x 8°, HA PEEK, Ta |
| M711591417081 | HAcancellous PEEK-C, 14L x 17W x 8H x 8°, HA PEEK, Ta |
| M711591417071 | HAcancellous PEEK-C, 14L x 17W x 7H x 8°, HA PEEK, Ta |
| M711591417061 | HAcancellous PEEK-C, 14L x 17W x 6H x 8°, HA PEEK, Ta |
| M711591416121 | HAcancellous PEEK-C, 14L x 16W x 12H x 8°, HA PEEK, Ta |
| M711591416111 | HAcancellous PEEK-C, 14L x 16W x 11H x 8°, HA PEEK, Ta |
| M711591416101 | HAcancellous PEEK-C, 14L x 16W x 10H x 8°, HA PEEK, Ta |
| M711591416091 | HAcancellous PEEK-C, 14L x 16W x 9H x 8°, HA PEEK, Ta |
| M711591416081 | HAcancellous PEEK-C, 14L x 16W x 8H x 8°, HA PEEK, Ta |
| M711591315121 | HAcancellous PEEK-C, 13L x 15W x 12H x 8°, HA PEEK, Ta |
Trademark Results [HAcancellous]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HACANCELLOUS 97298736 not registered Live/Pending |
Innovasis, Inc. 2022-03-07 |
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