A-CIFT® SoloFuse®
GUDID 00190361021520
A-CIFT SoloFuse 4.2 Screw, Rigid, 15mm
SPINEFRONTIER, INC.
Polymeric spinal interbody fusion cage| Primary Device ID | 00190361021520 |
| NIH Device Record Key | 9e88d617-e040-4c8d-86e6-e7926637df36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A-CIFT® SoloFuse® |
| Version Model Number | 01-32010-15 |
| 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 | 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
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com |
Device Dimensions
| Outer Diameter | 4.2 Millimeter |
| Outer Diameter | 4.2 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190361021520 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131880
FDA Product Code
| OVE | Intervertebral fusion device with integrated fixation, cervical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190361021520]
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 | 2016-04-15 |
On-Brand Devices [A-CIFT® SoloFuse®]
| 00190361037408 | 13X17X12 AO TRIAL, LORDOTIC |
| 00190361037392 | 13X17X11 AO TRIAL, LORDOTIC |
| 00190361037385 | 13X17X10 AO TRIAL, LORDOTIC |
| 00190361037378 | 13X17X9 AO TRIAL, LORDOTIC |
| 00190361037361 | 13X17X8 AO TRIAL, LORDOTIC |
| 00190361037354 | 13X17X7 AO TRIAL, LORDOTIC |
| 00190361037347 | 13X17X6 AO TRIAL, LORDOTIC |
| 00190361037330 | 13X17X5 AO TRIAL, LORDOTIC |
| 00190361037323 | FREEHAND SLIM PEEK INSERTER |
| 00190361037316 | TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 12MM |
| 00190361037309 | TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 11MM |
| 00190361037293 | TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 10MM |
| 00190361037286 | TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 9MM |
| 00190361037279 | TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 8MM |
| 00190361037262 | TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 7MM |
| 00190361037255 | TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 6MM |
| 00190361037248 | TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 5MM |
| 00190361037231 | TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 12MM |
| 00190361037224 | TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 11MM |
| 00190361037217 | TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 10MM |
| 00190361037200 | TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 9MM |
| 00190361037194 | TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 8MM |
| 00190361037187 | TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 7MM |
| 00190361037170 | TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 6MM |
| 00190361037163 | TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 5MM |
| 00190361037156 | SLIM GUIDE, SLIM PEEK INSERTER - 12MM |
| 00190361037149 | SLIM GUIDE, SLIM PEEK INSERTER - 11MM |
| 00190361037132 | SLIM GUIDE, SLIM PEEK INSERTER - 10MM |
| 00190361037125 | SLIM GUIDE, SLIM PEEK INSERTER - 9MM |
| 00190361037118 | SLIM GUIDE, SLIM PEEK INSERTER - 8MM |
| 00190361037101 | SLIM GUIDE, SLIM PEEK INSERTER - 7MM |
| 00190361037095 | SLIM GUIDE, SLIM PEEK INSERTER - 6MM |
| 00190361037088 | SLIM GUIDE, SLIM PEEK INSERTER - 5MM |
| 00190361037071 | FREEHAND TIP, SLIM INSERTER |
| 00190361037064 | SLIM PEEK INSERTER ASSY |
| 00190361037057 | RETRACTABLE AWL |
| 00190361023722 | A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 12mm Height HA PEEK |
| 00190361023715 | A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 11mm Height HA PEEK |
| 00190361023708 | A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 10mm Height HA PEEK |
| 00190361023692 | A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 9mm Height HA PEEK |
| 00190361023685 | A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 8mm Height HA PEEK |
| 00190361023678 | A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 7mm Height HA PEEK |
| 00190361023661 | A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 6mm Height HA PEEK |
| 00190361023654 | A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 5mm Height HA PEEK |
| 00190361021636 | A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic 13LX17W, 12mm |
| 00190361021629 | A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic 13LX17W, 11mm |
| 00190361021612 | A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic 13LX17W, 10mm |
| 00190361021605 | A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic 13LX17W, 9mm |
| 00190361021599 | A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic 13LX17W, 8mm |
| 00190361021582 | A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic 13LX17W, 7mm |
Trademark Results [A-CIFT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 A-CIFT 85836823 4860094 Live/Registered |
SpineFrontier, Inc. 2013-01-30 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.