A-CIFT
GUDID 00190361026402
A-CIFT SoloFuse PEEK IBFD, 14Lx19W, 18°, 9MM, HA PEEK
SPINEFRONTIER, INC.
Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage| Primary Device ID | 00190361026402 |
| NIH Device Record Key | 4c3e5a9d-3133-46ac-9eb3-40dd93e00327 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A-CIFT |
| Version Model Number | 01-32025-1809-HA |
| 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 | 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 | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com |
Device Dimensions
| Height | 9 Millimeter |
| Angle | 18 degree |
| Width | 19 Millimeter |
| Length | 13.5 Millimeter |
| Height | 9 Millimeter |
| Angle | 18 degree |
| Width | 19 Millimeter |
| Length | 13.5 Millimeter |
| Height | 9 Millimeter |
| Angle | 18 degree |
| Width | 19 Millimeter |
| Length | 13.5 Millimeter |
| Height | 9 Millimeter |
| Angle | 18 degree |
| Width | 19 Millimeter |
| Length | 13.5 Millimeter |
| Height | 9 Millimeter |
| Angle | 18 degree |
| Width | 19 Millimeter |
| Length | 13.5 Millimeter |
| Height | 9 Millimeter |
| Angle | 18 degree |
| Width | 19 Millimeter |
| Length | 13.5 Millimeter |
| Height | 9 Millimeter |
| Angle | 18 degree |
| Width | 19 Millimeter |
| Length | 13.5 Millimeter |
| Height | 9 Millimeter |
| Angle | 18 degree |
| Width | 19 Millimeter |
| Length | 13.5 Millimeter |
| Height | 9 Millimeter |
| Angle | 18 degree |
| Width | 19 Millimeter |
| Length | 13.5 Millimeter |
| Height | 9 Millimeter |
| Angle | 18 degree |
| Width | 19 Millimeter |
| Length | 13.5 Millimeter |
| Height | 9 Millimeter |
| Angle | 18 degree |
| Width | 19 Millimeter |
| Length | 13.5 Millimeter |
| Height | 9 Millimeter |
| Angle | 18 degree |
| Width | 19 Millimeter |
| Length | 13.5 Millimeter |
| Height | 9 Millimeter |
| Angle | 18 degree |
| Width | 19 Millimeter |
| Length | 13.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190361026402 [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 | true |
[00190361026402]
Radiation Sterilization
[00190361026402]
Radiation Sterilization
[00190361026402]
Radiation Sterilization
[00190361026402]
Radiation Sterilization
[00190361026402]
Radiation Sterilization
[00190361026402]
Radiation Sterilization
[00190361026402]
Radiation Sterilization
[00190361026402]
Radiation Sterilization
[00190361026402]
Radiation Sterilization
[00190361026402]
Radiation Sterilization
[00190361026402]
Radiation Sterilization
[00190361026402]
Radiation Sterilization
[00190361026402]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-20 |
| Device Publish Date | 2020-07-10 |
On-Brand Devices [A-CIFT]
| 00190361028130 | A-CIFT TRIAL HEADS, 14x 19, 18°, 12MM |
| 00190361028123 | A-CIFT TRIAL HEADS, 14x 19, 18°, 11MM |
| 00190361028116 | A-CIFT TRIAL HEADS, 14x 19, 18°, 10MM |
| 00190361028109 | A-CIFT TRIAL HEADS, 14x 19, 18°, 9MM |
| 00190361028093 | A-CIFT TRIAL HEADS, 14x 19, 18°, 8MM |
| 00190361028086 | A-CIFT TRIAL HEADS, 14x 19, 18°, 7MM |
| 00190361028079 | A-CIFT TRIAL HEADS, 14x 19, 14°, 12MM |
| 00190361028062 | A-CIFT TRIAL HEADS, 14x 19, 14°, 11MM |
| 00190361028055 | A-CIFT TRIAL HEADS, 14x 19, 14°, 10MM |
| 00190361028048 | A-CIFT TRIAL HEADS, 14x 19, 14°, 9MM |
| 00190361028031 | A-CIFT TRIAL HEADS, 14x 19, 14°, 8MM |
| 00190361028024 | A-CIFT TRIAL HEADS, 14x 19, 14°, 6MM |
| 00190361028017 | A-CIFT TRIAL HEADS, 14x 19, 14°, 5MM |
| 00190361028000 | A-CIFT TRIAL HEADS, 14x 19, 10°, 12MM |
| 00190361027997 | A-CIFT TRIAL HEADS, 14x 19, 10°, 11MM |
| 00190361027980 | A-CIFT TRIAL HEADS, 14x 19, 10°, 10MM |
| 00190361027973 | A-CIFT TRIAL HEADS, 14x 19, 10°, 9MM |
| 00190361027966 | A-CIFT TRIAL HEADS, 14x 19, 10°, 8MM |
| 00190361027959 | A-CIFT TRIAL HEADS, 14x 19, 10°, 7MM |
| 00190361027942 | A-CIFT TRIAL HEADS, 14x 19, 10°, 6MM |
| 00190361027935 | A-CIFT TRIAL HEADS, 14x 19, 10°, 5MM |
| 00190361027928 | A-CIFT TRIAL HEADS, 14x 19, 6°, 12MM |
| 00190361027911 | A-CIFT TRIAL HEADS, 14x 19, 6°, 11MM |
| 00190361027904 | A-CIFT TRIAL HEADS, 14x 19, 6°, 10MM |
| 00190361027898 | A-CIFT TRIAL HEADS, 14x 19, 6°, 9MM |
| 00190361027881 | A-CIFT TRIAL HEADS, 14x 19, 6°, 8MM |
| 00190361027874 | A-CIFT TRIAL HEADS, 14x 19, 6°, 7MM |
| 00190361027867 | A-CIFT TRIAL HEADS, 14x 19, 6°, 6MM |
| 00190361027850 | A-CIFT TRIAL HEADS, 14x 19, 6°, 5MM |
| 00190361027843 | A-CIFT TRIAL HEADS, 14x 17, 18°, 12MM |
| 00190361027836 | A-CIFT TRIAL HEADS, 14x 17, 18°, 11MM |
| 00190361027829 | A-CIFT TRIAL HEADS, 14x 17, 18°, 10MM |
| 00190361027812 | A-CIFT TRIAL HEADS, 14x 17, 18°, 9MM |
| 00190361027805 | A-CIFT TRIAL HEADS, 14x 17, 18°, 8MM |
| 00190361027799 | A-CIFT TRIAL HEADS, 14x 17, 18°, 7MM |
| 00190361027782 | A-CIFT TRIAL HEADS, 14x 17, 14°, 12MM |
| 00190361027775 | A-CIFT TRIAL HEADS, 14x 17, 14°, 11MM |
| 00190361027768 | A-CIFT TRIAL HEADS, 14x 17, 14°, 10MM |
| 00190361027751 | A-CIFT TRIAL HEADS, 14x 17, 14°, 9MM |
| 00190361027744 | A-CIFT TRIAL HEADS, 14x 17, 14°, 8MM |
| 00190361027737 | A-CIFT TRIAL HEADS, 14x 17, 14°, 7MM |
| 00190361027720 | A-CIFT TRIAL HEADS, 14x 17, 14°, 6MM |
| 00190361027713 | A-CIFT TRIAL HEADS, 14x 17, 10°, 12MM |
| 00190361027706 | A-CIFT TRIAL HEADS, 14x 17, 10°, 11MM |
| 00190361027690 | A-CIFT TRIAL HEADS, 14x 17, 10°, 10MM |
| 00190361027683 | A-CIFT TRIAL HEADS, 14x 17, 10°, 9MM |
| 00190361027676 | A-CIFT TRIAL HEADS, 14x 17, 10°, 8MM |
| 00190361027669 | A-CIFT TRIAL HEADS, 14x 17, 10°, 7MM |
| 00190361027652 | A-CIFT TRIAL HEADS, 14x 17, 10°, 6MM |
| 00190361027645 | A-CIFT TRIAL HEADS, 14x 17, 10°, 5MM |
Trademark Results [A-CIFT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 A-CIFT 85836823 4860094 Live/Registered |
SpineFrontier, Inc. 2013-01-30 |
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