Cervalign
GUDID 00810076561325
CervAlign, 4 LEVEL, 64MM
Surgalign Spine Technologies, Inc.
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 00810076561325 |
| NIH Device Record Key | 0af8ad5d-ffdb-4aeb-826b-535ef550a817 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cervalign |
| Version Model Number | 66-464 |
| Company DUNS | 014520584 |
| Company Name | Surgalign Spine Technologies, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810076561325 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K211408
FDA Product Code
| KWQ | Appliance, fixation, spinal intervertebral body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
[00810076561325]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-19 |
| Device Publish Date | 2023-06-09 |
On-Brand Devices [Cervalign]
| 00810076561776 | CERVALIGN, FST, 4.5MM, 20MM |
| 00810076561769 | CERVALIGN, FST, 4.5MM, 18MM |
| 00810076561752 | CERVALIGN, FST, 4.5MM, 16MM |
| 00810076561745 | CERVALIGN, FST, 4.5MM, 14MM |
| 00810076561738 | CERVALIGN, FST, 4.5MM, 12MM |
| 00810076561721 | CERVALIGN, FST, 4.5MM, 10MM |
| 00810076561714 | CERVALIGN, VST, 4.5MM, 20MM |
| 00810076561707 | CERVALIGN, VST, 4.5MM, 18MM |
| 00810076561691 | CERVALIGN, VST, 4.5MM, 16MM |
| 00810076561684 | CERVALIGN, VST, 4.5MM, 14MM |
| 00810076561677 | CERVALIGN, VST, 4.5MM, 12MM |
| 00810076561660 | CERVALIGN, VST, 4.5MM, 10MM |
| 00810076561653 | CERVALIGN, FST, 4.0MM, 20MM |
| 00810076561646 | CERVALIGN, FST, 4.0MM, 18MM |
| 00810076561639 | CERVALIGN, FST, 4.0MM, 16MM |
| 00810076561622 | CERVALIGN, FST, 4.0MM, 14MM |
| 00810076561615 | CERVALIGN, FST, 4.0MM, 12MM |
| 00810076561608 | CERVALIGN, FST, 4.0MM, 10MM |
| 00810076561592 | CERVALIGN, FSD, 4.0MM, 16MM |
| 00810076561585 | CERVALIGN, FSD, 4.0MM, 14MM |
| 00810076561578 | CERVALIGN, FSD, 4.0MM, 12MM |
| 00810076561561 | CERVALIGN, FSD, 4.0MM, 10MM |
| 00810076561554 | CERVALIGN, VST, 4.0MM, 20MM |
| 00810076561547 | CERVALIGN, VST, 4.0MM, 18MM |
| 00810076561530 | CERVALIGN, VST, 4.0MM, 16MM |
| 00810076561523 | CERVALIGN, VST, 4.0MM, 14MM |
| 00810076561516 | CERVALIGN, VST, 4.0MM, 12MM |
| 00810076561509 | CERVALIGN, VST, 4.0MM, 10MM |
| 00810076561493 | CERVALIGN, VSD, 4.0MM, 16MM |
| 00810076561486 | CERVALIGN, VSD, 4.0MM, 14MM |
| 00810076561479 | CERVALIGN, VSD, 4.0MM, 12MM |
| 00810076561462 | CERVALIGN, VSD, 4.0MM, 10MM |
| 00810076561455 | CervAlign, 5 LEVEL, 105MM |
| 00810076561448 | CervAlign, 5 LEVEL, 100MM |
| 00810076561431 | CervAlign, 5 LEVEL, 95MM |
| 00810076561424 | CervAlign, 5 LEVEL, 90MM |
| 00810076561417 | CervAlign, 5 LEVEL, 85MM |
| 00810076561400 | CervAlign, 5 LEVEL, 80MM |
| 00810076561394 | CervAlign, 5 LEVEL, 75MM |
| 00810076561387 | CervAlign, 4 LEVEL, 88MM |
| 00810076561370 | CervAlign, 4 LEVEL, 84MM |
| 00810076561363 | CervAlign, 4 LEVEL, 80MM |
| 00810076561356 | CervAlign, 4 LEVEL, 76MM |
| 00810076561349 | CervAlign, 4 LEVEL, 72MM |
| 00810076561332 | CervAlign, 4 LEVEL, 68MM |
| 00810076561325 | CervAlign, 4 LEVEL, 64MM |
| 00810076561318 | CervAlign, 4 LEVEL, 60MM |
| 00810076561301 | CervAlign, 3 LEVEL, 63MM |
| 00810076561295 | CervAlign, 3 LEVEL, 60MM |
| 00810076561288 | CervAlign, 3 LEVEL, 57MM |
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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