A-CIFT
GUDID 00190361025993
A-CIFT SoloFuse PEEK IBFD, 16Lx19W, 10°, 8MM, HA PEEK
SPINEFRONTIER, INC.
Polymeric spinal interbody fusion cage| Primary Device ID | 00190361025993 |
| NIH Device Record Key | 266ebe0b-484d-4c65-8670-b0c68c07e3eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A-CIFT |
| Version Model Number | 01-32024-1008-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
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Angle | 10 degree |
| Width | 19 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Angle | 10 degree |
| Width | 19 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Angle | 10 degree |
| Width | 19 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Angle | 10 degree |
| Width | 19 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Angle | 10 degree |
| Width | 19 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Angle | 10 degree |
| Width | 19 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Angle | 10 degree |
| Width | 19 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Angle | 10 degree |
| Width | 19 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Angle | 10 degree |
| Width | 19 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Angle | 10 degree |
| Width | 19 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Angle | 10 degree |
| Width | 19 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Angle | 10 degree |
| Width | 19 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Angle | 10 degree |
| Width | 19 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190361025993 [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 |
[00190361025993]
Radiation Sterilization
[00190361025993]
Radiation Sterilization
[00190361025993]
Radiation Sterilization
[00190361025993]
Radiation Sterilization
[00190361025993]
Radiation Sterilization
[00190361025993]
Radiation Sterilization
[00190361025993]
Radiation Sterilization
[00190361025993]
Radiation Sterilization
[00190361025993]
Radiation Sterilization
[00190361025993]
Radiation Sterilization
[00190361025993]
Radiation Sterilization
[00190361025993]
Radiation Sterilization
[00190361025993]
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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