Cervalign
GUDID 00840311247912
Cervalign, Rigid Screw Inserter, Sleeve
Xtant Medical Holdings, Inc.
Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable 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 |
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
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.
| 00840311247912 - Cervalign | 2024-04-15Cervalign, Rigid Screw Inserter, Sleeve |
| 00840311247912 - Cervalign | 2024-04-15 Cervalign, Rigid Screw Inserter, Sleeve |
| M697C02210000 - Fortex Pedicle Screw System | 2023-05-18 Special Adjustment Screwdriver Assembly Non-cannulated |
| M697C02200191 - Fortex Pedicle Screw System | 2023-04-06 4.75mm Special Single Lead Tap |
| M697C02200201 - Fortex Pedicle Screw System | 2023-04-06 5.5mm Special Single Lead Tap |
| M697C02200211 - Fortex Pedicle Screw System | 2023-04-06 6.5mm Special Single Lead Tap |
| M697C02200221 - Fortex Pedicle Screw System | 2023-04-06 7.5mm Special Single Lead Tap |
| M697C02200231 - Fortex Pedicle Screw System | 2023-04-06 8.25mm Special Single Lead Tap |
| M697C03410001 - Calix Lumbar Spinal Implant System | 2023-03-07 ASSEMBLY, SPECIAL INSERTER |
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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