PSX

GUDID 00190376397061

PSX Lordotic Expandable, 12 x 18 x 25mm, 20°

ALPHATEC SPINE, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00190376397061
• NIH Device Record Key: 9fc521e3-5464-42dc-8008-607f5266de9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PSX
• Version Model Number: 320-12182500
• 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

Device Dimensions

• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter
• Height: 12 Millimeter
• Width: 18 Millimeter
• Angle: 20 degree
• Length: 25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376397061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211873

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

[00190376397061]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-31
• Device Publish Date: 2022-01-22

On-Brand Devices [PSX]

• 00190376397078: PSX Lordotic Expandable, 12 x 18 x 30mm, 20°
• 00190376397061: PSX Lordotic Expandable, 12 x 18 x 25mm, 20°
• 00190376397054: PSX Lordotic Expandable, 12 x 14 x 30mm, 20°
• 00190376397047: PSX Lordotic Expandable, 12 x 14 x 25mm, 20°
• 00190376397030: PSX Lordotic Expandable, 12 x 10 x 30mm, 20°
• 00190376397023: PSX Lordotic Expandable, 12 x 10 x 25mm, 20°
• 00190376397016: PSX Lordotic Expandable, 11 x 18 x 30mm, 20°
• 00190376397009: PSX Lordotic Expandable, 11 x 18 x 25mm, 20°
• 00190376396996: PSX Lordotic Expandable, 11 x 14 x 30mm, 20°
• 00190376396989: PSX Lordotic Expandable, 11 x 14 x 25mm, 20°
• 00190376396972: PSX Lordotic Expandable, 11 x 10 x 30mm, 20°
• 00190376396965: PSX Lordotic Expandable, 11 x 10 x 25mm, 20°
• 00190376396958: PSX Lordotic Expandable, 10 x 18 x 30mm, 20°
• 00190376396941: PSX Lordotic Expandable, 10 x 18 x 25mm, 20°
• 00190376396934: PSX Lordotic Expandable, 10 x 14 x 30mm, 20°
• 00190376396927: PSX Lordotic Expandable, 10 x 14 x 25mm, 20°
• 00190376396910: PSX Lordotic Expandable, 10 x 10 x 30mm, 20°
• 00190376396903: PSX Lordotic Expandable, 10 x 10 x 25mm, 20°
• 00190376396897: PSX Lordotic Expandable, 9 x 18 x 30mm, 20°
• 00190376396880: PSX Lordotic Expandable, 9 x 18 x 25mm, 20°
• 00190376396873: PSX Lordotic Expandable, 9 x 14 x 30mm, 20°
• 00190376396866: PSX Lordotic Expandable, 9 x 14 x 25mm, 20°
• 00190376396859: PSX Lordotic Expandable, 9 x 10 x 30mm, 20°
• 00190376396842: PSX Lordotic Expandable, 9 x 10 x 25mm, 20°
• 00190376396835: PSX Lordotic Expandable, 8 x 18 x 30mm, 20°
• 00190376396828: PSX Lordotic Expandable, 8 x 18 x 25mm, 20°
• 00190376396811: PSX Lordotic Expandable, 8 x 14 x 30mm, 20°
• 00190376396804: PSX Lordotic Expandable, 8 x 14 x 25mm, 20°
• 00190376396798: PSX Lordotic Expandable, 8 x 10 x 30mm, 20°
• 00190376396781: PSX Lordotic Expandable, 8 x 10 x 25mm, 20°
• 00190376396774: PSX Lordotic Expandable, 7 x 18 x 30mm, 20°
• 00190376396767: PSX Lordotic Expandable, 7 x 18 x 25mm, 20°
• 00190376396750: PSX Lordotic Expandable, 7 x 14 x 30mm, 20°
• 00190376396743: PSX Lordotic Expandable, 7 x 14 x 25mm, 20°
• 00190376396736: PSX Lordotic Expandable, 7 x 10 x 30mm, 20°
• 00190376383095: 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, BLACK
• 00190376383088: 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, YELLOW
• 00190376383071: 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, FUSCHIA
• 00190376383064: 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, DARK BLUE
• 00190376383057: 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, GREEN
• 00190376383040: 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, DARK GREY
• 00190376383033: 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, GREY
• 00190376383026: 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, COOL GREY
• 00190376364445: 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 20 IN-LBS, BLACK
• 00190376364438: 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 20 IN-LBS, YELLOW
• 00190376364421: 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 20 IN-LBS, FUCHSIA
• 00190376364414: 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 20 IN-LBS, DARK BLUE
• 00190376364407: 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 20 IN-LBS, GREEN
• 00190376364391: 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 20 IN-LBS, DARK GREY
• 00190376364384: 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 20 IN-LBS, GREY