| Primary Device ID | 09351327000657 |
| NIH Device Record Key | 2245a5ad-5d54-47b9-a2ee-7a86bc56645d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Optimized Ortho Positioning (OPS) System |
| Version Model Number | 1248-0038 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 09351327000657 [Primary] |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09351327000657]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-19 |
| Device Publish Date | 2020-02-11 |
| 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 |