Optimized Positioning System (OPS) Femoral

GUDID 09351327000084

Patient Specific Femoral Guide+Trial Femoral Head

OPTIMIZED ORTHO PTY LTD

Custom-made orthopaedic surgical guide, non-sterile

• Primary Device ID: 09351327000084
• NIH Device Record Key: 84651b88-796d-48c0-80a2-dd1c1cf614bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optimized Positioning System (OPS) Femoral
• Version Model Number: 1250-1100,1250-1200
• 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: true
• 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	09351327000084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181061

FDA Product Code

• PBF: Orthopaedic Surgical Planning And Instrument Guides

Sterilization

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

[09351327000084]

Moist Heat or Steam Sterilization

[09351327000084]

Moist Heat or Steam Sterilization

[09351327000084]

Moist Heat or Steam Sterilization

[09351327000084]

Moist Heat or Steam Sterilization

[09351327000084]

Moist Heat or Steam Sterilization

[09351327000084]

Moist Heat or Steam Sterilization

[09351327000084]

Moist Heat or Steam Sterilization

[09351327000084]

Moist Heat or Steam Sterilization

[09351327000084]

Moist Heat or Steam Sterilization

[09351327000084]

Moist Heat or Steam Sterilization

[09351327000084]

Moist Heat or Steam Sterilization

[09351327000084]

Moist Heat or Steam Sterilization

[09351327000084]

Moist Heat or Steam Sterilization

[09351327000084]

Moist Heat or Steam Sterilization

[09351327000084]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-26
• Device Publish Date: 2019-04-18

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