Arena-L®
GUDID 00190361038696
Flat Trial Head, 35X26 Lordotic 8°, 11L
SPINEFRONTIER, INC.
Polymeric spinal interbody fusion cage| Primary Device ID | 00190361038696 |
| NIH Device Record Key | b212f102-a0d7-4d00-bedb-397788405c10 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Arena-L® |
| Version Model Number | 11-81022-11 |
| 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 | 00190361038696 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111553
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190361038696]
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-L®]
| 00190361039358 | 21X27 TRIAL HEAD, ARENA-L ALLO, 20MM |
| 00190361039341 | 21X27 TRIAL HEAD, ARENA-L ALLO, 18MM |
| 00190361039334 | 21X27 TRIAL HEAD, ARENA-L ALLO, 16MM |
| 00190361039327 | 21X27 TRIAL HEAD, ARENA-L ALLO, 14MM |
| 00190361039310 | 21X27 TRIAL HEAD, ARENA-L ALLO, 12MM |
| 00190361039303 | 21X27 TRIAL HEAD, ARENA-L ALLO, 10MM |
| 00190361039297 | 21X27 TRIAL HEAD, ARENA-L ALLO, 8MM |
| 00190361039280 | 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 20MM |
| 00190361039273 | 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 18MM |
| 00190361039266 | 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 16MM |
| 00190361039259 | 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 14MM |
| 00190361039242 | 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 12MM |
| 00190361039235 | 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 10MM |
| 00190361039228 | 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 8MM |
| 00190361039211 | 21X27 TRIAL HEAD, ARENA-L ALLO, 21MM |
| 00190361039204 | 21X27 TRIAL HEAD, ARENA-L ALLO, 19MM |
| 00190361039198 | 21X27 TRIAL HEAD, ARENA-L ALLO, 17MM |
| 00190361039181 | 21X27 TRIAL HEAD, ARENA-L ALLO, 15MM |
| 00190361039174 | 21X27 TRIAL HEAD, ARENA-L ALLO, 13MM |
| 00190361039167 | 21X27 TRIAL HEAD, ARENA-L ALLO, 11MM |
| 00190361039150 | 21X27 TRIAL HEAD, ARENA-L ALLO, 9MM |
| 00190361039143 | 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 21MM |
| 00190361039136 | 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 19MM |
| 00190361039129 | 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 17MM |
| 00190361039112 | 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 15MM |
| 00190361039105 | 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 13MM |
| 00190361039099 | 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 11MM |
| 00190361039082 | 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 9MM |
| 00190361039075 | 7MM 21X27 TRIAL, ARENA-L ALLO |
| 00190361039068 | 7MM 21X27 TRIAL RASP, ARENA-L ALLO |
| 00190361039051 | Rasp Trial Head, 38X28 Lordotic 12°, 17L |
| 00190361039044 | Rasp Trial Head, 38X28 Lordotic 12°, 15L |
| 00190361039037 | Rasp Trial Head, 38X28 Lordotic 12°, 13L |
| 00190361039020 | Rasp Trial Head, 38X28 Lordotic 12°, 11L |
| 00190361039013 | Rasp Trial Head, 35X26 Lordotic 12°, 17L |
| 00190361039006 | Rasp Trial Head, 35X26 Lordotic 12°, 15L |
| 00190361038993 | Rasp Trial Head, 35X26 Lordotic 12°, 13L |
| 00190361038986 | Rasp Trial Head, 35X26 Lordotic 12°, 11L |
| 00190361038979 | Rasp Trial Head, 38X28 Lordotic 8°, 17L |
| 00190361038962 | Rasp Trial Head, 38X28 Lordotic 8°, 15L |
| 00190361038955 | Rasp Trial Head, 38X28 Lordotic 8°, 13L |
| 00190361038948 | Rasp Trial Head, 38X28 Lordotic 8°, 11L |
| 00190361038931 | Rasp Trial Head, 38X28 Lordotic 8°, 9L |
| 00190361038924 | Flat Trial Head, 38X28 Lordotic 8°, 19L |
| 00190361038917 | Flat Trial Head, 38X28 Lordotic 8°, 17L |
| 00190361038900 | Flat Trial Head, 38X28 Lordotic 8°, 15L |
| 00190361038894 | Flat Trial Head, 38X28 Lordotic 8°, 13L |
| 00190361038887 | Flat Trial Head, 38X28 Lordotic 8°, 11L |
| 00190361038870 | Flat Trial Head, 38X28 Lordotic 8°, 9L |
| 00190361038863 | Rasp Trial Head, 35X26 Lordotic 8° 17L |
Trademark Results [Arena-L]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARENA-L 85648864 4408106 Live/Registered |
SpineFrontier, Inc. 2012-06-11 |
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