DUALX TLIF LOCKOUT SCREW

GUDID B707125300320

DUALX TLIF LOCKOUT SCREW Rev A

AMPLIFY SURGICAL, INC.

Metallic spinal fusion cage, sterile 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: B707125300320
• NIH Device Record Key: 220fa6be-c464-431f-af26-b6970804cd38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALX TLIF LOCKOUT SCREW
• Version Model Number: 12530032
• Company DUNS: 081021000
• Company Name: AMPLIFY SURGICAL, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM
• Phone: 7652675439
• Email: UDI@AMPLIFYSURGICAL.COM

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707125300320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181397

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-16
• Device Publish Date: 2019-05-08

On-Brand Devices [DUALX TLIF LOCKOUT SCREW]

• B70712530032A0: DUALX TLIF LOCKOUT SCREW
• B707125300320: DUALX TLIF LOCKOUT SCREW Rev A