Optimized Ortho Positioning (OPS) System

GUDID 09351327000596

Impactor Canister Adaptor 39mm

OPTIMIZED ORTHO PTY LTD

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 09351327000596
• NIH Device Record Key: c62b71fa-9055-4a18-9d38-f89de53b3376
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optimized Ortho Positioning (OPS) System
• Version Model Number: 1248-0005
• 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: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09351327000596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152893

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

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

[09351327000596]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-19
• Device Publish Date: 2020-02-11

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

• 09351327000275: Short Curved Guide Handle Screwdriver
• 09351327000268: Short Curved Guide Handle Screw
• 09351327000251: Long Curved Guide Handle
• 09351327000244: Short Curved Guide Handle
• 09351327000237: Reference Arm Long
• 09351327000220: Reference Arm Short
• 09351327000213: Right Angle Clamp
• 09351327000206: Impactor Canister Adaptor 42.5mm
• 09351327000190: Reamer Adaptor Stryker
• 09351327000183: Canister Clamp
• 09351327000176: Reference Post
• 09351327000169: Laser Canister
• 09351327000152: Laser Canister Cap
• 09351327000145: Pelvic Screw Attachment
• 09351327000138: Pelvic Screw Short
• 09351327000121: Pelvic Screw Long
• 09351327000114: T-Handle Introducer Assembly
• 09351327000107: Impactor Canister Adaptor 39mm
• 09351327000015: Trial Acetabulum
• 09351327000008: Patient Specific Acetabular Guide
• 09351327000657: Laser Canister
• 09351327000640: Laser Canister Cap
• 09351327000633: Pelvic Screw Attachment
• 09351327000626: Pelvic Screw Short
• 09351327000619: Pelvic Screw Long
• 09351327000602: T-Handle Introducer
• 09351327000596: Impactor Canister Adaptor 39mm
• 09351327001364: OPS Reusable Instrument Outer Tray with Lid
• 09351327001302: OPS Reusable Instrument Inner Tray