OPS™ FHA

GUDID 09351327000374

OPTIMIZED ORTHO PTY LTD

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software

• Primary Device ID: 09351327000374
• NIH Device Record Key: 72de73fa-c937-484c-9c25-92bf8d9d7215
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPS™ FHA
• Version Model Number: 1205-0001
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09351327000374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190834

FDA Product Code

• PLW: Acetabular Cup Orientation System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-19
• Device Publish Date: 2019-11-11

Devices Manufactured by OPTIMIZED ORTHO PTY LTD

• 09351327001302 - Optimized Ortho Positioning (OPS) System: 2022-06-03 OPS Reusable Instrument Inner Tray
• 09351327001364 - Optimized Ortho Positioning (OPS) System: 2022-06-03 OPS Reusable Instrument Outer Tray with Lid
• 09351327000848 - OPSInsight™: 2021-03-24 OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection,
• 09351327000695 - OPS: 2020-02-25 Impactor Canister Adaptor 42.5mm
• 09351327000701 - OPS: 2020-02-25 Right Angle Clamp
• 09351327000718 - OPS: 2020-02-25 Reference Arm Short
• 09351327000725 - OPS: 2020-02-25 Reference Arm Long
• 09351327000732 - OPS: 2020-02-25 Short Curved Guide Handle