Device Type ID | 4708 |
Device Name | Ceramics, Calcium Triphosphate/hydroxypatite, Non-load Bearing Uses |
Review Panel | Orthopedic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Restorative And Repair Devices Branch (RRDB) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | LMN |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4708 |
Device | Ceramics, Calcium Triphosphate/hydroxypatite, Non-load Bearing Uses |
Product Code | LMN |
FDA Device Classification | Class 3 Medical Device |