Additive Orthopaedics Wedge Osteotomy System

GUDID 00850005508243

Additive Orthopaedics Locking Evans Wedge - 20X8

ADDITIVE ORTHOPAEDICS LLC

Metallic osteotomy fusion cage, sterile

• Primary Device ID: 00850005508243
• NIH Device Record Key: c830a9c4-1c70-476a-818e-369490a57f7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Additive Orthopaedics Wedge Osteotomy System
• Version Model Number: AOLEW-20-8
• 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	00850005508243 [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: 2019-07-24
• Device Publish Date: 2019-07-16

On-Brand Devices [Additive Orthopaedics Wedge Osteotomy System]

• 00850005508274: Additive Orthopaedics Locking Evans Wedge - 22x10
• 00850005508267: Additive Orthopaedics Locking Evans Wedge - 22x8
• 00850005508250: Additive Orthopaedics Locking Evans Wedge - 20X10
• 00850005508243: Additive Orthopaedics Locking Evans Wedge - 20X8
• 00850005508236: Additive Orthopaedics Locking Evans Wedge - 18X10
• 00850005508229: Additive Orthopaedics Locking Evans Wedge - 18X8