Fortex Pedicle Screw System

GUDID M697X0646555C1

Assembly, Fortex, 6.5 x 55 Cannulated Mini Reduction Screw

Xtant Medical Holdings, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDM697X0646555C1
NIH Device Record Key38ee0c72-a79a-412a-9244-fe2787e8c584
Commercial Distribution StatusIn Commercial Distribution
Brand NameFortex Pedicle Screw System
Version Model NumberX064-6555C
Company DUNS081224143
Company NameXtant Medical Holdings, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com

Device Dimensions

Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697X0646555C1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M697X0646555C1]

Moist Heat or Steam Sterilization

[M697X0646555C1]

Moist Heat or Steam Sterilization

[M697X0646555C1]

Moist Heat or Steam Sterilization

[M697X0646555C1]

Moist Heat or Steam Sterilization

[M697X0646555C1]

Moist Heat or Steam Sterilization

[M697X0646555C1]

Moist Heat or Steam Sterilization

[M697X0646555C1]

Moist Heat or Steam Sterilization

[M697X0646555C1]

Moist Heat or Steam Sterilization

[M697X0646555C1]

Moist Heat or Steam Sterilization

[M697X0646555C1]

Moist Heat or Steam Sterilization

[M697X0646555C1]

Moist Heat or Steam Sterilization

[M697X0646555C1]

Moist Heat or Steam Sterilization

[M697X0646555C1]

Moist Heat or Steam Sterilization

[M697X0646555C1]

Moist Heat or Steam Sterilization

[M697X0646555C1]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-06-03
Device Publish Date2015-10-26

On-Brand Devices [Fortex Pedicle Screw System]

M697X07707201CoCr, 5.5mm Dia Bar X 500mm w/End stop
M697X07707191CoCr, 5.5mm Dia Bar X 300mm w/End stop
M697X07707181CoCr, 5.5mm Dia Bar X 200mm w/End stop
M697X07707171CoCr, 5.5mm Dia Bar X 180mm w/End stop
M697X07707161CoCr, 5.5mm Dia Bar X 160mm w/End stop
M697X07707151CoCr, 5.5mm Dia Bar X 140mm w/End stop
M697X07707141CoCr, 5.5mm Dia Bar X 120mm w/End stop
M697X07707131CoCr, 5.5mm Dia Bar X 100mm w/End stop
M697X07707121CoCr, 5.5mm Dia Bar X 95mm w/End stop
M697X07707111CoCr, 5.5mm Dia Bar X 90mm w/End stop
M697X07707101CoCr, 5.5mm Dia Bar X 85mm w/End stop
M697X07707091CoCr, 5.5mm Dia Bar X 80mm w/End stop
M697X07707081CoCr, 5.5mm Dia Bar X 75mm w/End stop
M697X07707071CoCr, 5.5mm Dia Bar X 70mm w/End stop
M697X07707061CoCr, 5.5mm Dia Bar X 65mm w/End stop
M697X07707051CoCr, 5.5mm Dia Bar X 60mm w/End stop
M697X07707041CoCr, 5.5mm Dia Bar X 55mm w/End stop
M697X07707031CoCr, 5.5mm Dia Bar X 50mm w/End stop
M697X07707021CoCr, 5.5mm Dia Bar X 45mm w/End stop
M697X07707011CoCr, 5.5mm Dia Bar X 40mm w/End stop
M697X07707001CoCr, 5.5mm Dia Bar X 35mm w/End stop
M697X07706191CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 160mm
M697X07706181CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 150mm
M697X07706171CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 140mm
M697X07706161CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 130mm
M697X07706151CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 120mm
M697X07706141CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 110mm
M697X07706131CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 100mm
M697X07706121CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 95mm
M697X07706111CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 90mm
M697X07706101CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 85mm
M697X07706091CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 80mm
M697X07706081CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 75mm
M697X07706071CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 70mm
M697X07706061CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 65mm
M697X07706051CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 60mm
M697X07706041CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 55mm
M697X07706031CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 50mm
M697X07706021CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 45mm
M697X07706011CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 40mm
M697X07706001CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 35mm
M697X07705191CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 300mm
M697X07705181CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 200mm
M697X07705171CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 180mm
M697X07705161CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 160mm
M697X07705151CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 140mm
M697X07705141CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 120mm
M697X07705131CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 100mm
M697X07705121CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 95mm
M697X07705111CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 90mm
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