DUALX PLIF 8 DEG x 9-12MM

GUDID B707128210000050

PLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Collapsed Width (mm): 12.32 Expanded Width (mm): 21.1 Collapsed Height (mm): 9.21 Expanded Height (mm): 12.5 Collapsed Length (mm): 39.69 Expanded Length (mm): 33.4

AMPLIFY SURGICAL, INC.

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• Primary Device ID: B707128210000050
• NIH Device Record Key: ba943fc7-a2eb-45a6-a5c5-a2fa39d86990
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALX PLIF 8 DEG x 9-12MM
• Version Model Number: 12821000005
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707128210000050 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-07-23

On-Brand Devices [DUALX PLIF 8 DEG x 9-12MM]

• B70712821000005A0: PLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Lateral Width: 21.1 mm Superior - Inferior Height
• B707128210000050: PLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Collapsed Width (mm): 12.32 Expanded Width (mm):