Additive Orthopaedics MTP Cup and Cone Bone Segment

GUDID 00850005508328

Additive Orthopaedics MTP Cup and Cone Bone Segment 10mmx18mm

ADDITIVE ORTHOPAEDICS LLC

Metallic osteotomy fusion cage, sterile

• Primary Device ID: 00850005508328
• NIH Device Record Key: 4ba541c0-48b8-48af-ae9a-01c798fbdc21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Additive Orthopaedics MTP Cup and Cone Bone Segment
• Version Model Number: AOMTPW-10-18
• 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	00850005508328 [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 MTP Cup and Cone Bone Segment]

• 00850005508397: Additive Orthopaedics MTP Cup and Cone Bone Segment 14mmx16mm
• 00850005508380: Additive Orthopaedics MTP Cup and Cone Bone Segment 12mmx16mm
• 00850005508373: Additive Orthopaedics MTP Cup and Cone Bone Segment 10mmx16mm
• 00850005508366: Additive Orthopaedics MTP Cup and Cone Bone Segment 8mmx16mm
• 00850005508359: Additive Orthopaedics MTP Cup and Cone Bone Segment 6mmx16mm
• 00850005508342: Additive Orthopaedics MTP Cup and Cone Bone Segment 14mmx18mm
• 00850005508335: Additive Orthopaedics MTP Cup and Cone Bone Segment 12mmx18mm
• 00850005508328: Additive Orthopaedics MTP Cup and Cone Bone Segment 10mmx18mm
• 00850005508311: Additive Orthopaedics MTP Cup and Cone Bone Segment 8mmx18mm
• 00850005508304: Additive Orthopaedics MTP Cup and Cone Bone Segment 6mmx18mm