Arena-C®
GUDID 00190361036418
Trial Spacer, Center Stop, Assembly, Lordotic, 5mm
SPINEFRONTIER, INC.
Polymeric spinal interbody fusion cage| Primary Device ID | 00190361036418 |
| NIH Device Record Key | e2d93f9c-4b60-4133-a952-d7ca51701b60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Arena-C® |
| Version Model Number | 11-72061-05 |
| Company DUNS | 002003243 |
| Company Name | SPINEFRONTIER, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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(866)914-7717 |
| customerservice@spinefrontier.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190361036418 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141337
FDA Product Code
| ODP | Intervertebral fusion device with bone graft, cervical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190361036418]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2016-10-05 |
On-Brand Devices [Arena-C®]
| 00190361037040 | Trial Rasp, No Stop, Assembly, Straight, 12mm |
| 00190361037033 | Trial Rasp, No Stop, Assembly, Straight, 11mm |
| 00190361037026 | Trial Rasp, No Stop, Assembly, Straight, 10mm |
| 00190361037019 | Trial Rasp, No Stop, Assembly, Straight, 9mm |
| 00190361037002 | Trial Rasp, No Stop, Assembly, Straight, 8mm |
| 00190361036999 | Trial Rasp, No Stop, Assembly, Straight, 7mm |
| 00190361036982 | Trial Rasp, No Stop, Assembly, Straight, 6mm |
| 00190361036975 | Trial Rasp, No Stop, Assembly, Straight, 5mm |
| 00190361036968 | Trial Rasp, Assembly, Straight, 12mm |
| 00190361036951 | Trial Rasp, Assembly, Straight, 11mm |
| 00190361036944 | Trial Rasp, Assembly, Straight, 10mm |
| 00190361036937 | Trial Rasp, Assembly, Straight, 9mm |
| 00190361036920 | Trial Rasp, Assembly, Straight, 8mm |
| 00190361036913 | Trial Rasp, Assembly, Straight, 7mm |
| 00190361036906 | Trial Rasp, Assembly, Straight, 6mm |
| 00190361036890 | Trial Rasp, Assembly, Straight, 5mm |
| 00190361036883 | Trial Rasp, No Stop, Assembly, Lordotic, 12mm |
| 00190361036876 | Trial Rasp, No Stop, Assembly, Lordotic, 11mm |
| 00190361036869 | Trial Rasp, No Stop, Assembly, Lordotic, 10mm |
| 00190361036852 | Trial Rasp, No Stop, Assembly, Lordotic, 9mm |
| 00190361036845 | Trial Rasp, No Stop, Assembly, Lordotic, 8mm |
| 00190361036838 | Trial Rasp, No Stop, Assembly, Lordotic, 7mm |
| 00190361036821 | Trial Rasp, No Stop, Assembly, Lordotic, 6mm |
| 00190361036814 | Trial Rasp, No Stop, Assembly, Lordotic, 5mm |
| 00190361036807 | Trial Rasp, Assembly, Lordotic, 12mm |
| 00190361036791 | Trial Rasp, Assembly, Lordotic, 11mm |
| 00190361036784 | Trial Rasp, Assembly, Lordotic, 10mm |
| 00190361036777 | Trial Rasp, Assembly, Lordotic, 9mm |
| 00190361036760 | Trial Rasp, Assembly, Lordotic, 8mm |
| 00190361036753 | Trial Rasp, Assembly, Lordotic, 7mm |
| 00190361036746 | Trial Rasp, Assembly, Lordotic, 6mm |
| 00190361036739 | Trial Rasp, Assembly, Lordotic, 5mm |
| 00190361036722 | 13X15 Trial Spacer, No Stop, Straight, 12mm |
| 00190361036715 | 13X15 Trial Spacer, No Stop, Straight, 11mm |
| 00190361036708 | 13X15 Trial Spacer, No Stop, Straight, 10mm |
| 00190361036692 | 13X15 Trial Spacer, No Stop, Straight, 9mm |
| 00190361036685 | 13X15 Trial Spacer, No Stop, Straight, 8mm |
| 00190361036678 | 13X15 Trial Spacer, No Stop, Straight, 7mm |
| 00190361036661 | 13X15 Trial Spacer, No Stop, Straight, 6mm |
| 00190361036654 | 13X15 Trial Spacer, No Stop, Straight, 5mm |
| 00190361036647 | Trial Spacer, Assembly, Straight, 12mm |
| 00190361036630 | Trial Spacer, Assembly, Straight, 11mm |
| 00190361036623 | Trial Spacer, Assembly, Straight, 10mm |
| 00190361036616 | Trial Spacer, Assembly, Straight, 9mm |
| 00190361036609 | Trial Spacer, Assembly, Straight, 8mm |
| 00190361036593 | Trial Spacer, Assembly, Straight, 7mm |
| 00190361036586 | Trial Spacer, Assembly, Straight, 6mm |
| 00190361036579 | Trial Spacer, Assembly, Straight, 5mm |
| 00190361036562 | 13X15 Trial Spacer, No Stop, Lordotic, 12mm |
| 00190361036555 | 13X15 Trial Spacer, No Stop, Lordotic, 11mm |
Trademark Results [Arena-C]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARENA-C 85836783 4392274 Live/Registered |
SpineFrontier, Inc. 2013-01-30 |
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