| Primary Device ID | M697X02200861 |
| NIH Device Record Key | 3b645ad0-aae6-4fcb-a3e8-1f151b384a44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fortex Pedicle Screw System |
| Version Model Number | X022-0086 |
| Company DUNS | 081224143 |
| Company Name | Xtant Medical Holdings, 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 |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M697X02200861 [Primary] |
| MNH | Orthosis, spondylolisthesis spinal fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
[M697X02200861]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-06-03 |
| Device Publish Date | 2015-10-14 |
| M697X07707201 | CoCr, 5.5mm Dia Bar X 500mm w/End stop |
| M697X07707191 | CoCr, 5.5mm Dia Bar X 300mm w/End stop |
| M697X07707181 | CoCr, 5.5mm Dia Bar X 200mm w/End stop |
| M697X07707171 | CoCr, 5.5mm Dia Bar X 180mm w/End stop |
| M697X07707161 | CoCr, 5.5mm Dia Bar X 160mm w/End stop |
| M697X07707151 | CoCr, 5.5mm Dia Bar X 140mm w/End stop |
| M697X07707141 | CoCr, 5.5mm Dia Bar X 120mm w/End stop |
| M697X07707131 | CoCr, 5.5mm Dia Bar X 100mm w/End stop |
| M697X07707121 | CoCr, 5.5mm Dia Bar X 95mm w/End stop |
| M697X07707111 | CoCr, 5.5mm Dia Bar X 90mm w/End stop |
| M697X07707101 | CoCr, 5.5mm Dia Bar X 85mm w/End stop |
| M697X07707091 | CoCr, 5.5mm Dia Bar X 80mm w/End stop |
| M697X07707081 | CoCr, 5.5mm Dia Bar X 75mm w/End stop |
| M697X07707071 | CoCr, 5.5mm Dia Bar X 70mm w/End stop |
| M697X07707061 | CoCr, 5.5mm Dia Bar X 65mm w/End stop |
| M697X07707051 | CoCr, 5.5mm Dia Bar X 60mm w/End stop |
| M697X07707041 | CoCr, 5.5mm Dia Bar X 55mm w/End stop |
| M697X07707031 | CoCr, 5.5mm Dia Bar X 50mm w/End stop |
| M697X07707021 | CoCr, 5.5mm Dia Bar X 45mm w/End stop |
| M697X07707011 | CoCr, 5.5mm Dia Bar X 40mm w/End stop |
| M697X07707001 | CoCr, 5.5mm Dia Bar X 35mm w/End stop |
| M697X07706191 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 160mm |
| M697X07706181 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 150mm |
| M697X07706171 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 140mm |
| M697X07706161 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 130mm |
| M697X07706151 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 120mm |
| M697X07706141 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 110mm |
| M697X07706131 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 100mm |
| M697X07706121 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 95mm |
| M697X07706111 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 90mm |
| M697X07706101 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 85mm |
| M697X07706091 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 80mm |
| M697X07706081 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 75mm |
| M697X07706071 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 70mm |
| M697X07706061 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 65mm |
| M697X07706051 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 60mm |
| M697X07706041 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 55mm |
| M697X07706031 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 50mm |
| M697X07706021 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 45mm |
| M697X07706011 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 40mm |
| M697X07706001 | CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 35mm |
| M697X07705191 | CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 300mm |
| M697X07705181 | CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 200mm |
| M697X07705171 | CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 180mm |
| M697X07705161 | CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 160mm |
| M697X07705151 | CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 140mm |
| M697X07705141 | CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 120mm |
| M697X07705131 | CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 100mm |
| M697X07705121 | CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 95mm |
| M697X07705111 | CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 90mm |