Additive Orthopaedics TMT Wedge

GUDID 00850005508298

Additive Orthopaedics TMT Wedge 18mmx7mm

ADDITIVE ORTHOPAEDICS LLC

Metallic osteotomy fusion cage, sterile

• Primary Device ID: 00850005508298
• NIH Device Record Key: 16db6d68-8b6f-4773-bf94-cb5b0a0a0ef1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Additive Orthopaedics TMT Wedge
• Version Model Number: AOTMTW-18-7
• Company DUNS: 085503457
• Company Name: ADDITIVE ORTHOPAEDICS LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 732-882-6633
• Email: greg@additiveorthopaedics.com
• Phone: 732-882-6633
• Email: greg@additiveorthopaedics.com
• Phone: 732-882-6633
• Email: greg@additiveorthopaedics.com
• Phone: 732-882-6633
• Email: greg@additiveorthopaedics.com
• Phone: 732-882-6633
• Email: greg@additiveorthopaedics.com
• Phone: 732-882-6633
• Email: greg@additiveorthopaedics.com
• Phone: 732-882-6633
• Email: greg@additiveorthopaedics.com
• Phone: 732-882-6633
• Email: greg@additiveorthopaedics.com
• Phone: 732-882-6633
• Email: greg@additiveorthopaedics.com
• Phone: 732-882-6633
• Email: greg@additiveorthopaedics.com
• Phone: 732-882-6633
• Email: greg@additiveorthopaedics.com
• Phone: 732-882-6633
• Email: greg@additiveorthopaedics.com
• Phone: 732-882-6633
• Email: greg@additiveorthopaedics.com
• Phone: 732-882-6633
• Email: greg@additiveorthopaedics.com
• Phone: 732-882-6633
• Email: greg@additiveorthopaedics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005508298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153207

FDA Product Code

• HRS: Plate, Fixation, Bone

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: 2019-08-01
• Device Publish Date: 2019-07-24

On-Brand Devices [Additive Orthopaedics TMT Wedge]

• 00850005508298: Additive Orthopaedics TMT Wedge 18mmx7mm
• 00850005508281: Additive Orthopaedics TMT Wedge 18mmx5mm