dualX T-HANDLE

GUDID B707125341100

Dual X T-Handle

AMPLIFY SURGICAL, INC.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: B707125341100
• NIH Device Record Key: 45d397df-7f7f-4c42-b6d9-3d4aecdb1b06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: dualX T-HANDLE
• Version Model Number: 12534110
• 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
• 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	B707125341100 [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

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

[B707125341100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-04
• Device Publish Date: 2020-07-27

On-Brand Devices [dualX T-HANDLE]

• B707125341050: Dual X T-Handle
• B707125341100: Dual X T-Handle