KIT DUALX PLIF 8 DEG x 8-10MM

GUDID B707128220010140

PLIF Lordosis & Heights: 8° x 8-10mm Collapsed Width (mm): 12.32 Expanded Width (mm): 21.1 Collapsed Height (mm): 8 Expanded Height (mm): 10 Collapsed Length (mm): 39.69 Expanded Length (mm): 33.4 PLIF SCREW

Amplify Surgical, 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

• Primary Device ID: B707128220010140
• NIH Device Record Key: 6063014e-13d0-400a-a6f3-07f1db153f76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIT DUALX PLIF 8 DEG x 8-10MM
• Version Model Number: 12822001014
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707128220010140 [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: 2022-03-09
• Device Publish Date: 2022-03-01

On-Brand Devices [KIT DUALX PLIF 8 DEG x 8-10MM]

• B707128230010140: PLIF Lordosis & Heights: 8° x 8-10mm Collapsed Width (mm): 12.32 Expanded Width (mm): 21.1 Coll
• B707128220010140: PLIF Lordosis & Heights: 8° x 8-10mm Collapsed Width (mm): 12.32 Expanded Width (mm): 21.1 Coll