Hexanium® PLIF PL2-CM148
GUDID 03663136005393
Ti PLIF Cage
SPINEVISION
Metallic spinal interbody fusion cage| Primary Device ID | 03663136005393 |
| NIH Device Record Key | 3edc879f-a06b-4837-99c0-470517ac169a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hexanium® PLIF |
| Version Model Number | PL2-CM148 |
| Catalog Number | PL2-CM148 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03663136005393 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223251
FDA Product Code
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-04 |
| Device Publish Date | 2025-01-27 |
On-Brand Devices [Hexanium® PLIF]
Trademark Results [Hexanium]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEXANIUM 79230101 5567878 Live/Registered |
SPINEVISION 2018-02-15 |
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