Additive Orthopaedics Locking Lattice System

GUDID 00850005508458

Additive Orthopaedics Utility Plate - 4 Hole

ADDITIVE ORTHOPAEDICS LLC

Metallic osteotomy fusion cage, sterile

• Primary Device ID: 00850005508458
• NIH Device Record Key: f180ea31-547c-4a8e-b3f2-c7e831a91f5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Additive Orthopaedics Locking Lattice System
• Version Model Number: AOLLP-NL
• 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	00850005508458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170214

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: 2019-08-27
• Device Publish Date: 2019-08-19

On-Brand Devices [Additive Orthopaedics Locking Lattice System]

• 00850005508489: Additive Orthopaedics MPJ Plate Right
• 00850005508472: Additive Orthopaedics MPJ Plate Left
• 00850005508465: Additive Orthopaedics MPJ Plate Straight
• 00850005508458: Additive Orthopaedics Utility Plate - 4 Hole
• 00850005508441: Additive Orthopaedics Locking Lattice Connection Screw
• 00850005508434: Additive Orthopaedics Locking Lattice 4 Hole Plate
• 00850005508427: Additive Orthopaedics Locking Lattice 3 Hole Plate
• 00850005508410: Additive Orthopaedics Locking Lattice 2 Hole Plate