SOLANAS Posterior Stabilization System

GUDID 00844856006621

Polyaxial Posterior Thoracic Screw, 3.5mm X 20mm

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system

• Primary Device ID: 00844856006621
• NIH Device Record Key: c32204ea-a45f-4883-96b0-b0eec1dd132b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLANAS Posterior Stabilization System
• Version Model Number: 63035-20
• 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

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856006621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052201
• Premarket Notification: K191185

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

Moist Heat or Steam Sterilization

[00844856006621]

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 [SOLANAS Posterior Stabilization System]

• 00190376065250: CoCr 2 Posterior Cervical Rod, 3.3mm X 240mm
• 00190376065243: CoCr 2 Posterior Cervical Rod, 3.3mm X 235mm
• 00190376065236: CoCr 2 Posterior Cervical Rod, 3.3mm X 230mm
• 00190376065229: CoCr 2 Posterior Cervical Rod, 3.3mm X 225mm
• 00190376065212: CoCr 2 Posterior Cervical Rod, 3.3mm X 220mm
• 00190376065205: CoCr 2 Posterior Cervical Rod, 3.3mm X 215mm
• 00190376065199: CoCr 2 Posterior Cervical Rod, 3.3mm X 210mm
• 00190376065182: CoCr 2 Posterior Cervical Rod, 3.3mm X 205mm
• 00190376065175: CoCr 2 Posterior Cervical Rod, 3.3mm X 200mm
• 00190376065168: CoCr 2 Posterior Cervical Rod, 3.3mm X 195mm
• 00190376065151: CoCr 2 Posterior Cervical Rod, 3.3mm X 190mm
• 00190376065144: CoCr 2 Posterior Cervical Rod, 3.3mm X 185mm
• 00190376065137: CoCr 2 Posterior Cervical Rod, 3.3mm X 180mm
• 00190376065120: CoCr 2 Posterior Cervical Rod, 3.3mm X 175mm
• 00190376065113: CoCr 2 Posterior Cervical Rod, 3.3mm X 170mm
• 00190376065106: CoCr 2 Posterior Cervical Rod, 3.3mm X 165mm
• 00190376065090: CoCr 2 Posterior Cervical Rod, 3.3mm X 160mm
• 00190376065083: CoCr 2 Posterior Cervical Rod, 3.3mm X 155mm
• 00190376065076: CoCr 2 Posterior Cervical Rod, 3.3mm X 150mm
• 00190376065069: CoCr 2 Posterior Cervical Rod, 3.3mm X 145mm
• 00190376065052: CoCr 2 Posterior Cervical Rod, 3.3mm X 140mm
• 00190376065045: CoCr 2 Posterior Cervical Rod, 3.3mm X 135mm
• 00190376065038: CoCr 2 Posterior Cervical Rod, 3.3mm X 130mm
• 00190376065021: CoCr 2 Posterior Cervical Rod, 3.3mm X 125mm
• 00190376065014: CoCr 2 Posterior Cervical Rod, 3.3mm X 120mm
• 00190376065007: CoCr 2 Posterior Cervical Rod, 3.3mm X 115mm
• 00190376064994: CoCr 2 Posterior Cervical Rod, 3.3mm X 110mm
• 00190376064987: CoCr 2 Posterior Cervical Rod, 3.3mm X 105mm
• 00190376064970: CoCr 2 Posterior Cervical Rod, 3.3mm X 100mm
• 00190376064963: CoCr 2 Posterior Cervical Rod, 3.3mm X 95mm
• 00190376064956: CoCr 2 Posterior Cervical Rod, 3.3mm X 90mm
• 00190376064949: CoCr 2 Posterior Cervical Rod, 3.3mm X 85mm
• 00190376064932: CoCr 2 Posterior Cervical Rod, 3.3mm X 80mm
• 00190376064925: CoCr 2 Posterior Cervical Rod, 3.3mm X 75mm
• 00190376064918: CoCr 2 Posterior Cervical Rod, 3.3mm X 70mm
• 00190376064901: CoCr 2 Posterior Cervical Rod, 3.3mm X 65mm
• 00190376064895: CoCr 2 Posterior Cervical Rod, 3.3mm X 60mm
• 00190376064888: CoCr 2 Posterior Cervical Rod, 3.3mm X 55mm
• 00190376064871: CoCr 2 Posterior Cervical Rod, 3.3mm X 50mm
• 00190376064864: CoCr 2 Posterior Cervical Rod, 3.3mm X 45mm
• 00190376064857: CoCr 2 Posterior Cervical Rod, 3.3mm X 40mm
• 00190376064840: CoCr 2 Posterior Cervical Rod, 3.3mm X 35mm
• 00190376064833: CoCr 2 Posterior Cervical Rod, 3.3mm X 30mm
• 00190376064826: CoCr 2 Posterior Cervical Rod, 3.3mm X 25mm
• 00190376064819: CoCr 2 Posterior Cervical Rod, 3.3mm X 20mm
• 00190376062921: CoCr Posterior Cervical Rod, 3.3mm X 240mm
• 00190376062914: CoCr Posterior Cervical Rod, 3.3mm X 235mm
• 00190376062907: CoCr Posterior Cervical Rod, 3.3mm X 230mm
• 00190376062891: CoCr Posterior Cervical Rod, 3.3mm X 225mm
• 00190376062884: CoCr Posterior Cervical Rod, 3.3mm X 220mm