Additive Orthopaedic Bone Wedge System

GUDID 00850005508137

Cotton Bone Segment - 18x14x10x5.5

ADDITIVE ORTHOPAEDICS LLC

Metallic osteotomy fusion cage, sterile

• Primary Device ID: 00850005508137
• NIH Device Record Key: ecbdc81f-30f2-4a28-af0e-d048462ca657
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Additive Orthopaedic Bone Wedge System
• Version Model Number: AOCW-18-5.5
• 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	00850005508137 [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: 2019-03-13
• Device Publish Date: 2019-03-05

On-Brand Devices [Additive Orthopaedic Bone Wedge System]

• 00850005508175: Cotton Bone Segment - 20x14x10x6.5
• 00850005508168: Cotton Bone Segment - 20x14x10x5.5
• 00850005508151: Cotton Bone Segment - 20x14x10x4.5
• 00850005508144: Cotton Bone Segment - 18x14x10x6.5
• 00850005508137: Cotton Bone Segment - 18x14x10x5.5
• 00850005508120: Cotton Bone Segment - 18x14x10x4.5
• 00850005508113: Cotton Bone Segment - 16x14x10x6.5
• 00850005508106: Cotton Bone Segment - 16x14x10x5.5
• 00850005508090: Cotton Bone Segment - 16x14x10x4.5
• 00850005508083: Evans Bone Segment - 22x22x12
• 00850005508076: Evans Bone Segment - 22x22x10
• 00850005508069: Evans Bone Segment - 22x22x8
• 00850005508052: Evans Bone Segment - 20x20x12
• 00850005508045: Evans Bone Segment - 20x20x10
• 00850005508038: Evans Bone Segment - 20x20x8
• 00850005508021: Evans Bone Segment - 18x18x12
• 00850005508014: Evans Bone Segment - 18x18x10
• 00850005508007: Evans Bone Segment - 18x18x8