Additive Orthopaedics Hammertoe System

GUDID 00850005508199

Additive Orthopaedics Hammertoe System - Includes 3.0/3.9 Angled Implant - ST

ADDITIVE ORTHOPAEDICS LLC

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00850005508199
• NIH Device Record Key: 7243f67b-cc85-42f5-8e73-055e6369fc3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Additive Orthopaedics Hammertoe System
• Version Model Number: AOHT3019Ai
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005508199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160264

FDA Product Code

• HTY: Pin, Fixation, Smooth

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 Hammertoe System]

• 00850005508212: Additive Orthopaedics Hammertoe System - Includes 3.0/3.9 Non-Cannulated Implant - ST
• 00850005508205: Additive Orthopaedics Hammertoe System - Includes 3.0/3.9 Cannulated Implant - ST
• 00850005508199: Additive Orthopaedics Hammertoe System - Includes 3.0/3.9 Angled Implant - ST
• 00850005508182: Additive Orthopaedics Hammertoe Implant - 3.0x3.2x18mm, Non-Cannulated