Hexanium® ACIF
GUDID 03663136000633
Lordotic Ti SA Cervical Cage
SPINEVISION
Metallic spinal interbody fusion cage| Primary Device ID | 03663136000633 |
| NIH Device Record Key | 65c681ec-433d-4d8c-8b25-eb44ba8c30f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hexanium® ACIF |
| Version Model Number | AC2-CSL09L |
| Company DUNS | 390377518 |
| Company Name | SPINEVISION |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com |
Device Dimensions
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03663136000633 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193000
FDA Product Code
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-10-26 |
| Device Publish Date | 2020-11-09 |
On-Brand Devices [Hexanium® ACIF]
| 03663136000442 | Convex Ti SA Cervical Cage |
| 03663136000855 | Ti Standard Cervical Tray |
| 03663136000848 | Ti SA Cervical Tray |
| 03663136009186 | Cylindrical Snap-On Torque Limiting Handle |
| 03663136009179 | Screwdriver Shaft |
| 03663136000831 | Lordotic Ti SA Cervical Cage |
| 03663136000824 | Lordotic Ti SA Cervical Cage |
| 03663136000817 | Lordotic Ti SA Cervical Cage |
| 03663136000800 | Lordotic Ti SA Cervical Cage |
| 03663136000794 | Lordotic Ti SA Cervical Cage |
| 03663136000787 | Lordotic Ti SA Cervical Cage |
| 03663136000770 | Lordotic Ti SA Cervical Cage |
| 03663136000763 | Lordotic Ti SA Cervical Cage |
| 03663136000756 | Lordotic Ti SA Cervical Cage |
| 03663136000749 | Lordotic Ti SA Cervical Cage |
| 03663136000732 | Lordotic Ti SA Cervical Cage |
| 03663136000725 | Lordotic Ti SA Cervical Cage |
| 03663136000718 | Lordotic Ti SA Cervical Cage |
| 03663136000701 | Lordotic Ti SA Cervical Cage |
| 03663136000695 | Lordotic Ti SA Cervical Cage |
| 03663136000688 | Lordotic Ti SA Cervical Cage |
| 03663136000671 | Lordotic Ti SA Cervical Cage |
| 03663136000664 | Lordotic Ti SA Cervical Cage |
| 03663136000657 | Lordotic Ti SA Cervical Cage |
| 03663136000640 | Lordotic Ti SA Cervical Cage |
| 03663136000633 | Lordotic Ti SA Cervical Cage |
| 03663136000626 | Lordotic Ti SA Cervical Cage |
| 03663136000619 | Lordotic Ti SA Cervical Cage |
| 03663136000602 | Lordotic Ti SA Cervical Cage |
| 03663136000596 | Self-Drilling Screws |
| 03663136000589 | Self-Drilling Screws |
| 03663136000572 | Self-Drilling Screws |
| 03663136000565 | Self-Drilling Screws |
| 03663136000558 | Self-Drilling Screws |
| 03663136000541 | Self-Drilling Screws |
| 03663136000534 | Self-Drilling Screws |
| 03663136000527 | Self-Drilling Screws |
| 03663136000459 | Convex Ti SA Cervical Cage |
| 03663136000435 | Convex Ti SA Cervical Cage |
| 03663136000428 | Convex Ti SA Cervical Cage |
| 03663136000411 | Convex Ti SA Cervical Cage |
| 03663136000404 | Convex Ti SA Cervical Cage |
| 03663136000398 | Convex Ti SA Cervical Cage |
| 03663136000381 | Convex Ti SA Cervical Cage |
| 03663136000374 | Convex Ti SA Cervical Cage |
| 03663136000367 | Convex Ti SA Cervical Cage |
| 03663136000350 | Convex Ti SA Cervical Cage |
| 03663136000343 | Convex Ti SA Cervical Cage |
| 03663136000336 | Convex Ti SA Cervical Cage |
| 03663136000329 | Convex Ti SA Cervical Cage |
Trademark Results [Hexanium]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEXANIUM 79230101 5567878 Live/Registered |
SPINEVISION 2018-02-15 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.