Arsenal

GUDID 00190376077727

Polyaxial Reduction Screw, 6.5 mm x 50 mm

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190376077727
• NIH Device Record Key: 80956f67-397b-4f99-9d3e-842101c6c23a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arsenal
• Version Model Number: 47210-065-050
• 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

Device Dimensions

• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376077727 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161363

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

[00190376077727]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-10-07

On-Brand Devices [Arsenal]

• 00190376047027: 4.0 mm Tap, NI
• 00190376003788: 4.5 mm Drill, NI
• 00190376003764: 4.0 mm Drill, NI
• 00190376003740: 3.5 mm Drill, NI
• 00190376003726: 3.0 mm Drill, NI
• 00190376003702: Cannulated Reduction Polyaxial Screw Driver, NI
• 00190376003665: 10.0 mm Tap, NI
• 00190376003641: 9.5 mm Tap, NI
• 00190376003627: 9.0 mm Tap, NI
• 00190376003603: 8.5 mm Tap, NI
• 00190376003580: 8.0 mm Tap, NI
• 00190376003566: 7.5 mm Tap, NI
• 00190376003542: 7.0 mm Tap, NI
• 00190376003528: 6.5 mm Tap, NI
• 00190376003504: 6.0 mm Tap, NI
• 00190376003481: 5.5 mm Tap, NI
• 00190376003467: 5.0 mm Tap, NI
• 00190376003443: 4.5 mm Tap, NI
• 00190376003429: 4.3 mm Tap, NI
• 00190376003405: 4.5 mm Cannulated Drill, NI
• 00190376003382: 4.0 mm Cannulated Drill, NI
• 00190376003368: 3.5 mm Cannulated Drill, NI
• 00190376003344: 3.0 mm Cannulated Drill, NI
• 00190376003313: 10.5 mm Cannulated Tap, NI
• 00190376003290: 10.0 mm Cannulated Tap, NI
• 00190376003276: 9.5 mm Cannulated Tap, NI
• 00190376003252: 9.0 mm Cannulated Tap, NI
• 00190376003238: 8.5 mm Cannulated Tap, NI
• 00190376003214: 8.0 mm Cannulated Tap, NI
• 00190376003191: 7.5 mm Cannulated Tap, NI
• 00190376003177: 7.0 mm Cannulated Tap, NI
• 00190376003153: 6.5 mm Cannulated Tap, NI
• 00190376003139: 6.0 mm Cannulated Tap, NI
• 00190376003115: 5.5 mm Cannulated Tap, NI
• 00190376003092: 5.0 mm Cannulated Tap, NI
• 00190376003078: 4.5 mm Cannulated Tap, NI
• 00190376003054: 4.3 mm Cannulated Tap, NI
• 00190376002996: Reduction Polyaxial Screw Driver, NI
• 00190376002965: Polyaxial Screw Driver, NI
• 00190376002941: 7.5 mm Cannulated CBx Tap, NI
• 00190376002927: 7.0 mm Cannulated CBx Tap, NI
• 00190376002903: 6.5 mm Cannulated CBx Tap, NI
• 00190376002880: 6.0 mm Cannulated CBx Tap, NI
• 00190376002866: 5.5 mm Cannulated CBx Tap, NI
• 00190376002842: 5.0 mm Cannulated CBx Tap, NI
• 00190376002828: 4.5 mm Cannulated CBx Tap, NI
• 00190376002804: 7.5 mm CBx Tap, NI
• 00190376002781: 7.0 mm CBx Tap, NI
• 00190376002767: 6.5 mm CBx Tap, NI
• 00190376002743: 6.0 mm CBx Tap, NI