Optimized Positioning System (OPS) Plan

GUDID 09351327000091

OPS Plan V.2.0

OPTIMIZED ORTHO PTY LTD

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• Primary Device ID: 09351327000091
• NIH Device Record Key: e45777b7-5e13-4bb1-a755-11f123dad3fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optimized Positioning System (OPS) Plan
• Version Model Number: 1250-1300
• Company DUNS: 745735175
• Company Name: OPTIMIZED ORTHO PTY LTD
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09351327000091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183038

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-04-23

On-Brand Devices [Optimized Positioning System (OPS) Plan]

• 09351327000091: OPS Plan V.2.0
• 09351327000077: OPS Plan