Definition: Preparation Of Autologous Platelet Rich Plasma From A Small Sample Of Peripheral Blood For Mixing With Bone Graft To Improve Handling Characteristics.
| Device Type ID | 2438 |
| Device Name | Platelet And Plasma Separator For Bone Graft Handling |
| Physical State | May Include Centrifuge, Filters, Tubes, Syringes And Needles |
| Technical Method | Uses Centrifugal And/or Filtration Methods To Separate The Whole Blood Into Components, After Which The Platelet Rich Plasma Is Withdrawn. |
| Target Area | Blood Drawn From Peripheral Veins, PRP Applied To Bony Defects |
| Regulation Description | Automated Blood Cell Separator. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9245 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ORG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2438 |
| Device | Platelet And Plasma Separator For Bone Graft Handling |
| Product Code | ORG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Automated Blood Cell Separator. |
| CFR Regulation Number | 864.9245 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALLIANCE PARTNERS LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ARTHREX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CASCADE MEDICAL ENTERPRISES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DSM BIOMEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HARVEST | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
REGENLAB SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Inadequate User Interface | 4 |
Device Expiration Issue | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Label | 1 |
Inadequate Instructions For Non-Healthcare Professional | 1 |
Insufficient Information | 1 |
Device Handling Problem | 1 |
| Total Device Problems | 14 |