Cervalign
GUDID 00840311247912
Cervalign, Rigid Screw Inserter, Sleeve
Xtant Medical Holdings, Inc.
Surgical screwdriver, reusable| Primary Device ID | 00840311247912 |
| NIH Device Record Key | 2cf2d98f-fcc1-4c8e-8578-cfb0028dcf98 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cervalign |
| Version Model Number | 725-092 |
| Company DUNS | 081224143 |
| Company Name | Xtant Medical Holdings, 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 | 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 | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840311247912 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K211408
FDA Product Code
| HXX | Screwdriver |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
[00840311247912]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-15 |
| Device Publish Date | 2024-04-05 |
Devices Manufactured by Xtant Medical Holdings, Inc.
| M697T09402001 - Atrix-C Cervical Allograft Spacer | 2024-11-25 Cortical Inserter Tip |
| M697X09400071 - Atrix-C Cervical Allograft Spacer | 2024-11-25 SOFT CARRY CASE II, ATRIX-C SPACERS |
| M697X09400231 - Atrix-C Cervical Allograft Spacer | 2024-11-25 ATRIX-C CORTICAL/CANCELLOUS IMPLANT SOFT CARRY CASE |
| 00840311207435 - Cortera Spinal Fixation System | 2024-10-17 Rod, Ti, Prebent, 6.0x25 |
| 00840311207442 - Cortera Spinal Fixation System | 2024-10-17 Rod, Ti, Prebent, 6.0x30 |
| 00840311207459 - Cortera Spinal Fixation System | 2024-10-17 Rod, Ti, Prebent, 6.0x35 |
| 00840311207466 - Cortera Spinal Fixation System | 2024-10-17 Rod, Ti, Prebent, 6.0x40 |
| 00840311207473 - Cortera Spinal Fixation System | 2024-10-17 Rod, Ti, Prebent, 6.0x45 |
Trademark Results [Cervalign]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CERVALIGN 88037029 not registered Live/Pending |
Pioneer Surgical Technology, Inc. 2018-07-13 |
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