| Primary Device ID | M697C00300501 |
| NIH Device Record Key | 630fc2cc-0315-402a-997d-1678d8988174 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Calix-C Cervical Interbody Spacer |
| Version Model Number | C003-0050 |
| Company DUNS | 610042587 |
| Company Name | X-SPINE SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Width | 16 Millimeter |
| Length | 13 Millimeter |
| Height | 5 Millimeter |
| Angle | 7 degree |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M697C00300500 [Direct Marking] |
| HIBCC | M697C00300501 [Primary] |
| HTR | Rasp |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
[M697C00300501]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-22 |
| Device Publish Date | 2021-03-12 |
| M697T09400601 | Forceps Inserter, 15 x 18 |
| M697T09400591 | Forceps Inserter, 13 x 16 |
| M697C00300501 | Special 13mm x 16mm Lordotic Rasp, 5mm |