KIT DUALX PLIF 8 DEG x 8-11MM

GUDID B707128220000040

PLIF Lordosis & Heights: 8° x 8-11mm Collapsed Width (mm): 12.32 Expanded Width (mm): 21.1 Collapsed Height (mm): 8.21 Expanded Height (mm): 11.5 Collapsed Length (mm): 39.69 Expanded Length (mm): 33.4 PLIF SCREW

Amplify Surgical, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: B707128220000040
• NIH Device Record Key: 84fb1eef-1d3d-463e-9f82-e1255df3bcaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIT DUALX PLIF 8 DEG x 8-11MM
• Version Model Number: 12822000004
• 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	B707128220000040 [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 8-11MM]

• B70712823000004A0: PLIF Lordosis & Heights: 8° x 8-11mm Lateral Width: 21.1 mm Superior - Inferior Height: 11.5mm
• B707128230000040: PLIF Lordosis & Heights: 8° x 8-11mm Collapsed Width (mm): 12.32 Expanded Width (mm): 21.1 Coll
• B707128220000040: PLIF Lordosis & Heights: 8° x 8-11mm Collapsed Width (mm): 12.32 Expanded Width (mm): 21.1 Coll