| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 09351327000374 [Primary] |
| PLW | Acetabular Cup Orientation System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-19 |
| Device Publish Date | 2019-11-11 |
| 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 |