Arsenal Degenerative Spinal Fixation System

GUDID 00844856078987

Sacral Polyaxial Screw, 6.5mm X 115mm

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system

• Primary Device ID: 00844856078987
• NIH Device Record Key: e4a2ba89-17fd-457a-a8e8-697cfb195d70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arsenal Degenerative Spinal Fixation System
• Version Model Number: 47100-065-115
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, 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

Customer Support Contacts

• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 115 Millimeter
• Outer Diameter: 6.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856078987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133221
• Premarket Notification: K161363

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

[00844856078987]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

On-Brand Devices [Arsenal Degenerative Spinal Fixation System]

• 00844856088528: CoCr Straight Rod, 5.5mm X 125mm
• 00844856088511: CoCr Straight Rod, 5.5mm X 115mm
• 00844856088504: CoCr Straight Rod, 5.5mm X 105mm
• 00844856088498: Left In-Line Revision Connector, 5.5mm X 100mm
• 00844856088481: Left In-Line Revision Connector, 5.5mm X 60mm
• 00844856088474: Right In-line Revision Connector, 5.5mm X 100mm
• 00844856088467: Right In-line Revision Connector, 5.5mm X 60mm
• 00844856088450: Left Narrow Side-loading Revision Connector, 6.35mm X 100mm
• 00844856088443: Left Narrow Side-loading Revision Connector, 6.35mm X 60mm
• 00844856088436: Left Narrow Side-loading Revision Connector, 5.5mm X 100mm
• 00844856088429: Left Narrow Side-loading Revision Connector, 5.5mm X 60mm
• 00844856088412: Right Narrow Side-loading Revision Connector, 6.35mm X 100mm
• 00844856088405: Right Narrow Side-loading Revision Connector, 6.35mm X 60mm
• 00844856088399: Right Narrow Side-loading Revision Connector, 5.5mm X 100mm
• 00844856088382: Right Narrow Side-loading Revision Connector, 5.5mm X 60mm
• 00844856088375: Left Side-loading Revision Connector, 6.35mm X 100mm
• 00844856088368: Left Side-loading Revision Connector, 6.35mm X 60mm
• 00844856088351: Left Side-loading Revision Connector, 5.5mm X 100mm
• 00844856088344: Left Side-loading Revision Connector, 5.5mm X 60mm
• 00844856088337: Right Side-loading Revision Connector, 6.35mm X 100mm
• 00844856088320: Right Side-loading Revision Connector, 6.35mm X 60mm
• 00844856088313: Right Side-loading Revision Connector, 5.5mm X 100mm
• 00844856088306: Right Side-loading Revision Connector, 5.5mm X 60mm
• 00844856088290: Axial Rod Connector, 5.5 X 6.35 X 30mm
• 00844856088283: Axial Rod Connector, 5.5 X 6.0 X 30mm
• 00844856088276: Connector Set Screw
• 00844856088269: Side Loading Connector Set Screw
• 00844856088252: Variable Bridge, Clamp Screw
• 00844856088245: Rod Set Screw
• 00844856088238: CP Ti Straight Rod, 5.5mm X 125mm
• 00844856088221: CP Ti Straight Rod, 5.5mm X 115mm
• 00844856088214: CP Ti Straight Rod, 5.5mm X 105mm
• 00844856088207: Ti Alloy Straight Rod, 5.5mm X 125mm
• 00844856088191: Ti Alloy Straight Rod, 5.5mm X 115mm
• 00844856088184: Ti Alloy Straight Rod, 5.5mm X 105mm
• 00844856088177: Polyaxial Reduction Screw, 10.5mm X 130mm
• 00844856088160: Polyaxial Reduction Screw, 10.5mm X 125mm
• 00844856088153: Polyaxial Reduction Screw, 10.5mm X 120mm
• 00844856088146: Polyaxial Reduction Screw, 10.5mm X 115mm
• 00844856088139: Polyaxial Reduction Screw, 10.5mm X 110mm
• 00844856088122: Polyaxial Reduction Screw, 10.5mm X 105mm
• 00844856088115: Polyaxial Reduction Screw, 10.5mm X 100mm
• 00844856088108: Polyaxial Reduction Screw, 10.5mm X 95mm
• 00844856088092: Polyaxial Reduction Screw, 10.5mm X 90mm
• 00844856088085: Polyaxial Reduction Screw, 10.5mm X 85mm
• 00844856088078: Polyaxial Reduction Screw, 10.5mm X 80mm
• 00844856088061: Polyaxial Reduction Screw, 10.5mm X 75mm
• 00844856088054: Polyaxial Reduction Screw, 10.5mm X 70mm
• 00844856088047: Polyaxial Reduction Screw, 10.5mm X 65mm
• 00844856088030: Polyaxial Reduction Screw, 10.5mm X 60mm