PSX

GUDID 00190376396873

PSX Lordotic Expandable, 9 x 14 x 30mm, 20°

ALPHATEC SPINE, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 00190376396873
• NIH Device Record Key: 98fa65b5-95b4-474b-a553-8ab7a1a8e905
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PSX
• Version Model Number: 320-09143000
• 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

• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter
• Width: 14 Millimeter
• Height: 9 Millimeter
• Angle: 20 degree
• Length: 30 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376396873 [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

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

Moist Heat or Steam Sterilization

[00190376396873]

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°
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• 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