Definition: Preparation Of Autologous Anti-inflammatory (AAI) Solution From A Small Sample Of Peripheral Blood For Treatment Of Osteoarthritis.
| Device Type ID | 2509 |
| Device Name | Peripheral Blood Processing Device For Osteoarthritis |
| Physical State | May Include Centrifuge, Filters, Tubes, Syringes, Needles, Other Disposables, And Anticoagulant. |
| Technical Method | Uses Centrifugal And/or Filtration Methods To Separate The Whole Blood Into Components, After Which The Autologous Anti-inflammatory (AAI) Solution Is Withdrawn. |
| Target Area | Blood Drawn From Peripheral Veins, AAI Applied To The Joint Via Intra-articular Injection. |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | Enforcement Discretion |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | PZT |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |