| Primary Device ID | M697X00310040 |
| NIH Device Record Key | 5cd6833f-20f2-4d09-a2bf-f11e7dd490c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Calix-C Cervical Interbody Spacer |
| Version Model Number | X003-1004 |
| Company DUNS | 081224143 |
| Company Name | Xtant Medical Holdings, 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 | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M697X00310040 [Direct Marking] |
| HIBCC | M697X00310041 [Primary] |
| LRP | TRAY, SURGICAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M697X00310040]
Moist Heat or Steam Sterilization
[M697X00310040]
Moist Heat or Steam Sterilization
[M697X00310040]
Moist Heat or Steam Sterilization
[M697X00310040]
Moist Heat or Steam Sterilization
[M697X00310040]
Moist Heat or Steam Sterilization
[M697X00310040]
Moist Heat or Steam Sterilization
[M697X00310040]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-18 |
| Device Publish Date | 2026-03-10 |
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| M697C00300520 | Special 13mm x 16mm Lordotic Rasp, 7mm |
| M697C00300510 | Special 13mm x 16mm Lordotic Rasp, 6mm |
| M697C00300590 | SPECIAL LORDOTIC RASP, 11mm x 14mm x 6mm |
| M697C00300580 | SPECIAL LORDOTIC RASP, 11mm x 14mm x 5mm |
| M697C00300600 | SPECIAL LORDOTIC RASP, 11mm x 14mm x 7mm |
| M697X00310040 | Lordotic Caddy, Calix Cervical |