| Primary Device ID | B528C09141260 |
| NIH Device Record Key | 9493cfd3-2dba-410a-b4e5-38e1f708a072 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Channel Cervical |
| Version Model Number | 1 |
| Catalog Number | C091412-6 |
| Company DUNS | 071012634 |
| Company Name | PANTHEON SPINAL, LLC |
| 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 |
| Phone | 5123083488 |
| info@pantheon-spinal.com | |
| Phone | 5123083488 |
| info@pantheon-spinal.com | |
| Phone | 5123083488 |
| info@pantheon-spinal.com | |
| Phone | 5123083488 |
| info@pantheon-spinal.com | |
| Phone | 5123083488 |
| info@pantheon-spinal.com | |
| Phone | 5123083488 |
| info@pantheon-spinal.com | |
| Phone | 5123083488 |
| info@pantheon-spinal.com | |
| Phone | 5123083488 |
| info@pantheon-spinal.com | |
| Phone | 5123083488 |
| info@pantheon-spinal.com | |
| Phone | 5123083488 |
| info@pantheon-spinal.com | |
| Phone | 5123083488 |
| info@pantheon-spinal.com | |
| Phone | 5123083488 |
| info@pantheon-spinal.com | |
| Phone | 5123083488 |
| info@pantheon-spinal.com | |
| Phone | 5123083488 |
| info@pantheon-spinal.com | |
| Phone | 5123083488 |
| info@pantheon-spinal.com | |
| Phone | 5123083488 |
| info@pantheon-spinal.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B528C09141260 [Primary] |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B528C09141260]
Moist Heat or Steam Sterilization
[B528C09141260]
Moist Heat or Steam Sterilization
[B528C09141260]
Moist Heat or Steam Sterilization
[B528C09141260]
Moist Heat or Steam Sterilization
[B528C09141260]
Moist Heat or Steam Sterilization
[B528C09141260]
Moist Heat or Steam Sterilization
[B528C09141260]
Moist Heat or Steam Sterilization
[B528C09141260]
Moist Heat or Steam Sterilization
[B528C09141260]
Moist Heat or Steam Sterilization
[B528C09141260]
Moist Heat or Steam Sterilization
[B528C09141260]
Moist Heat or Steam Sterilization
[B528C09141260]
Moist Heat or Steam Sterilization
[B528C09141260]
Moist Heat or Steam Sterilization
[B528C09141260]
Moist Heat or Steam Sterilization
[B528C09141260]
Moist Heat or Steam Sterilization
[B528C09141260]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-12 |
| Device Publish Date | 2021-02-04 |
| B528CO8141260 | SPACER CERVICAL 8MM 6 DEG PEEK |
| B528C09141260 | Spacer Cervical 9mm x 6 deg PEEK |