FortiFix 12101-8535N
GUDID 00814216027795
FortiFix (C) Screw, Ø8.5mm x 35mm, Solid, Cort/Can, Nano
NANOVIS SPINE, LLC
Spinal bone screw, non-bioabsorbable| Primary Device ID | 00814216027795 |
| NIH Device Record Key | 9f67ef62-9cd5-4d0b-a3c5-3dc61618cf38 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FortiFix |
| Version Model Number | 12101-8535N |
| Catalog Number | 12101-8535N |
| Company DUNS | 079898044 |
| Company Name | NANOVIS SPINE, LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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
Device Dimensions
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814216027795 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203452
FDA Product Code
| NKB | Thoracolumbosacral Pedicle Screw System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-17 |
| Device Publish Date | 2021-05-07 |
On-Brand Devices [FortiFix]
| 00814216026934 | FortiFix (S) Screw, Ø5.5mm x 30mm, Solid, Nano |
| 00814216027863 | FortiFix (C) Screw, Ø8.5mm x 80mm, Solid, Iliac, Nano |
| 00814216027856 | FortiFix (C) Screw, Ø8.5mm x 70mm, Solid, Iliac, Nano |
| 00814216027849 | FortiFix (C) Screw, Ø8.5mm x 60mm, Solid, Cort/Can, Nano |
| 00814216027832 | FortiFix (C) Screw, Ø8.5mm x 55mm, Solid, Cort/Can, Nano |
| 00814216027825 | FortiFix (C) Screw, Ø8.5mm x 50mm, Solid, Cort/Can, Nano |
| 00814216027818 | FortiFix (C) Screw, Ø8.5mm x 45mm, Solid, Cort/Can, Nano |
| 00814216027801 | FortiFix (C) Screw, Ø8.5mm x 40mm, Solid, Cort/Can, Nano |
| 00814216027795 | FortiFix (C) Screw, Ø8.5mm x 35mm, Solid, Cort/Can, Nano |
| 00814216027788 | FortiFix (C) Screw, Ø8.5mm x 30mm, Solid, Cort/Can, Nano |
| 00814216027771 | FortiFix (C) Screw, Ø7.5mm x 60mm, Solid, Cort/Can, Nano |
| 00814216027764 | FortiFix (C) Screw, Ø7.5mm x 55mm, Solid, Cort/Can, Nano |
| 00814216027757 | FortiFix (C) Screw, Ø7.5mm x 50mm, Solid, Cort/Can, Nano |
| 00814216027740 | FortiFix (C) Screw, Ø7.5mm x 45mm, Solid, Cort/Can, Nano |
| 00814216027733 | FortiFix (C) Screw, Ø7.5mm x 40mm, Solid, Cort/Can, Nano |
| 00814216027726 | FortiFix (C) Screw, Ø7.5mm x 35mm, Solid, Cort/Can, Nano |
| 00814216027719 | FortiFix (C) Screw, Ø7.5mm x 30mm, Solid, Cort/Can, Nano |
| 00814216027702 | FortiFix (C) Screw, Ø6.5mm x 60mm, Solid, Cort/Can, Nano |
| 00814216027696 | FortiFix (C) Screw, Ø6.5mm x 55mm, Solid, Cort/Can, Nano |
| 00814216027689 | FortiFix (C) Screw, Ø6.5mm x 50mm, Solid, Cort/Can, Nano |
| 00814216027672 | FortiFix (C) Screw, Ø6.5mm x 45mm, Solid, Cort/Can, Nano |
| 00814216027665 | FortiFix (C) Screw, Ø6.5mm x 40mm, Solid, Cort/Can, Nano |
| 00814216027658 | FortiFix (C) Screw, Ø6.5mm x 35mm, Solid, Cort/Can, Nano |
| 00814216027641 | FortiFix (C) Screw, Ø6.5mm x 30mm, Solid, Cort/Can, Nano |
| 00814216027634 | FortiFix (C) Screw, Ø5.5mm x 60mm, Solid, Cort/Can, Nano |
| 00814216027627 | FortiFix (C) Screw, Ø5.5mm x 55mm, Solid, Cort/Can, Nano |
| 00814216027610 | FortiFix (C) Screw, Ø5.5mm x 50mm, Solid, Cort/Can, Nano |
| 00814216027603 | FortiFix (C) Screw, Ø5.5mm x 45mm, Solid, Cort/Can, Nano |
| 00814216027597 | FortiFix (C) Screw, Ø5.5mm x 40mm, Solid, Cort/Can, Nano |
| 00814216027580 | FortiFix (C) Screw, Ø5.5mm x 35mm, Solid, Cort/Can, Nano |
| 00814216027573 | FortiFix (C) Screw, Ø5.5mm x 30mm, Solid, Cort/Can, Nano |
| 00814216027566 | FortiFix MIS Screw, Ø8.5mm x 80mm, Cann, Nano |
| 00814216027559 | FortiFix MIS Screw, Ø8.5mm x 75mm, Cann, Nano |
| 00814216027542 | FortiFix MIS Screw, Ø8.5mm x 70mm, Cann, Nano |
| 00814216027535 | FortiFix MIS Screw, Ø8.5mm x 65mm, Cann, Nano |
| 00814216027528 | FortiFix MIS Screw, Ø8.5mm x 60mm, Cann, Nano |
| 00814216027511 | FortiFix MIS Screw, Ø8.5mm x 55mm, Cann, Nano |
| 00814216027504 | FortiFix MIS Screw, Ø8.5mm x 50mm, Cann, Nano |
| 00814216027498 | FortiFix MIS Screw, Ø8.5mm x 45mm, Cann, Nano |
| 00814216027481 | FortiFix MIS Screw, Ø8.5mm x 40mm, Cann, Nano |
| 00814216027474 | FortiFix MIS Screw, Ø8.5mm x 35mm, Cann, Nano |
| 00814216027467 | FortiFix MIS Screw, Ø8.5mm x 30mm, Cann, Nano |
| 00814216027443 | FortiFix MIS Screw, Ø7.5mm x 55mm, Cann, Nano |
| 00814216027436 | FortiFix MIS Screw, Ø7.5mm x 50mm, Cann, Nano |
| 00814216027429 | FortiFix MIS Screw, Ø7.5mm x 45mm, Cann, Nano |
| 00814216027412 | FortiFix MIS Screw, Ø7.5mm x 40mm, Cann, Nano |
| 00814216027405 | FortiFix MIS Screw, Ø7.5mm x 35mm, Cann, Nano |
| 00814216027399 | FortiFix MIS Screw, Ø7.5mm x 30mm, Cann, Nano |
| 00814216027382 | FortiFix MIS Screw, Ø6.5mm x 60mm, Cann, Nano |
| 00814216027375 | FortiFix MIS Screw, Ø6.5mm x 55mm, Cann, Nano |
Trademark Results [FortiFix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FORTIFIX 85740398 4993654 Live/Registered |
Nanovis, LLC 2012-09-27 |
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