Arsenal CBx

GUDID 00844856093591

Cortico-Cancellous Screw 10.5mm X 50mm

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00844856093591
• NIH Device Record Key: d9988e06-3625-4789-b844-08e4dfd4b742
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arsenal CBx
• Version Model Number: 47400-105-050
• 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

Device Dimensions

• Outer Diameter: 105 Millimeter
• Outer Diameter: 105 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856093591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143149
• Premarket Notification: K161363

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

Moist Heat or Steam Sterilization

[00844856093591]

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: 2015-05-28

On-Brand Devices [Arsenal CBx]

• 00844856097322: Cortical Reduction Screw, 7.0mmX 60mm
• 00844856097315: Cortical Reduction Screw, 7.0mm X 55mm
• 00844856097308: Cortical Reduction Screw, 7.0mm X 50mm
• 00844856097292: Cortical Reduction Screw, 7.0mm X 45mm
• 00844856097285: Cortical Reduction Screw, 7.0mm X 40mm
• 00844856097278: Cortical Reduction Screw, 7.0mm X 35mm
• 00844856097261: Cortical Reduction Screw, 7.0mm X 30mm
• 00844856097254: Cortical Reduction Screw, 7.0mm X 25mm
• 00844856097247: Cortical Reduction Screw, 7.0mm X 20mm
• 00844856097230: Cortical Reduction Screw, 7.0mm X 15mm
• 00844856097223: Cortical Reduction Screw, 6.5mmX 60mm
• 00844856097216: Cortical Reduction Screw, 6.5mm X 55mm
• 00844856097209: Cortical Reduction Screw, 6.5mm X 50mm
• 00844856097193: Cortical Reduction Screw, 6.5mm X 45mm
• 00844856097186: Cortical Reduction Screw, 6.5mm X 40mm
• 00844856097179: Cortical Reduction Screw, 6.5mm X 35mm
• 00844856097162: Cortical Reduction Screw, 6.5mm X 30mm
• 00844856097155: Cortical Reduction Screw, 6.5mm X 25mm
• 00844856097148: Cortical Reduction Screw, 6.5mm X 20mm
• 00844856097131: Cortical Reduction Screw, 6.5mm X 15mm
• 00844856097124: Cortical Reduction Screw, 6.0mmX 60mm
• 00844856097117: Cortical Reduction Screw, 6.0mm X 55mm
• 00844856097100: Cortical Reduction Screw, 6.0mm X 50mm
• 00844856097094: Cortical Reduction Screw, 6.0mm X 45mm
• 00844856097087: Cortical Reduction Screw, 6.0mm X 40mm
• 00844856097070: Cortical Reduction Screw, 6.0mm X 35mm
• 00844856097063: Cortical Reduction Screw, 6.0mm X 30mm
• 00844856097056: Cortical Reduction Screw, 6.0mm X 25mm
• 00844856097049: Cortical Reduction Screw, 6.0mm X 20mm
• 00844856097032: Cortical Reduction Screw, 6.0mm X 15mm
• 00844856097025: Cortical Reduction Screw, 5.5mm X 60mm
• 00844856097018: Cortical Reduction Screw, 5.5mm X 55mm
• 00844856097001: Cortical Reduction Screw, 5.5mm X 50mm
• 00844856096998: Cortical Reduction Screw, 5.5mm X 45mm
• 00844856096981: Cortical Reduction Screw, 5.5mm X 40mm
• 00844856096974: Cortical Reduction Screw, 5.5mm X 35mm
• 00844856096967: Cortical Reduction Screw, 5.5mm X 30mm
• 00844856096950: Cortical Reduction Screw, 5.5mm X 25mm
• 00844856096943: Cortical Reduction Screw, 5.5mm X 20mm
• 00844856096936: Cortical Reduction Screw, 5.5mm X 15mm
• 00844856096929: Cortical Reduction Screw, 5.0mm X 60mm
• 00844856096912: Cortical Reduction Screw, 5.0mm X 55mm
• 00844856096905: Cortical Reduction Screw, 5.0mm X 50mm
• 00844856096899: Cortical Reduction Screw, 5.0mm X 45mm
• 00844856096882: Cortical Reduction Screw, 5.0mm X 40mm
• 00844856096875: Cortical Reduction Screw, 5.0mm X 35mm
• 00844856096868: Cortical Reduction Screw, 5.0mm X 30mm
• 00844856096851: Cortical Reduction Screw, 5.0mm X 25mm
• 00844856096844: Cortical Reduction Screw, 5.0mm X 20mm
• 00844856096837: Cortical Reduction Screw, 5.0mm X 15mm