DUALX DUAL PORTAL SERIAL DILATOR #5

GUDID B707MHSD2001US0

SERIAL DILATOR #5 US MANUFACTURE

AMPLIFY SURGICAL, INC.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: B707MHSD2001US0
• NIH Device Record Key: 98e722f4-05da-4bf1-8209-cbc6e569316f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALX DUAL PORTAL SERIAL DILATOR #5
• Version Model Number: MHSD2001US
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707MHSD2001US0 [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

[B707MHSD2001US0]

Moist Heat or Steam Sterilization

[B707MHSD2001US0]

Moist Heat or Steam Sterilization

[B707MHSD2001US0]

Moist Heat or Steam Sterilization

[B707MHSD2001US0]

Moist Heat or Steam Sterilization

[B707MHSD2001US0]

Moist Heat or Steam Sterilization

[B707MHSD2001US0]

Moist Heat or Steam Sterilization

[B707MHSD2001US0]

Moist Heat or Steam Sterilization

[B707MHSD2001US0]

Moist Heat or Steam Sterilization

[B707MHSD2001US0]

Moist Heat or Steam Sterilization

[B707MHSD2001US0]

Moist Heat or Steam Sterilization

[B707MHSD2001US0]

Moist Heat or Steam Sterilization

[B707MHSD2001US0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-06
• Device Publish Date: 2025-05-29

On-Brand Devices [DUALX DUAL PORTAL SERIAL DILATOR #5]

• B707MDSD20010: SERIAL DILATOR #5
• B707MHSD20010: SERIAL DILATOR #5
• B707MHSD2001US0: SERIAL DILATOR #5 US MANUFACTURE