DualX Fixed ACME Drawbar T/PLIF Short

GUDID B707128250070

DualX Fixed ACME Drawbar T/PLIF Short

Amplify Surgical, Inc.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: B707128250070
• NIH Device Record Key: 7c0900f6-bdd9-4bc2-bdc6-4706d8a8f209
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DualX Fixed ACME Drawbar T/PLIF Short
• Version Model Number: 12825007
• 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: false
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707128250070 [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: true
• Device Is Sterile: false

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

[B707128250070]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-20
• Device Publish Date: 2021-08-12

Devices Manufactured by Amplify Surgical, Inc.

• B707125342180 - DUALX ACME PIN: 2024-09-11 DUALX ACME PIN
• B707128440050 - DualXS Implant Retainer Shaft: 2024-09-11 DUALXS IMPLANT RETAINER SHAFT
• B707128450000 - DualXS Inserter Outer Shaft: 2024-09-11 DUALXS INSERTER OUTER SHAFT ASSEMBLY
• B707128450010 - DualXS Fixed ACME Drawbar: 2024-09-11 DualXS Fixed ACME Drawbar
• B707128450020 - DualXS Inserter Handle Acme: 2024-09-11 DualXS Inserter Handle Acme
• B707129410010040 - DUALXS T/PLIF 8 DEG x 7-9MM: 2024-06-28 Lordosis & Heights: 8° x 7-9mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 7 Expanded Height (mm):
• B707129410010050 - DUALXS T/PLIF 12 DEG x 7-10MM: 2024-06-28 Lordosis & Heights: 8° x 7-10mm Collapsed Width (mm): 12 Expanded Width (mm): 20 Collapsed Height (mm): 7 Expanded Height (mm):
• B707129410010120 - DUALXS T/PLIF 15 DEG x 8-11MM: 2024-06-28 Lordosis & Heights: 15° x 8-11mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 8 Expanded Height (mm)