Device Type ID | 4719 |
Device Name | Filler, Bone Void, Non-osteoinduction |
Review Panel | Orthopedic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | MBS |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4719 |
Device | Filler, Bone Void, Non-osteoinduction |
Product Code | MBS |
FDA Device Classification | Class 3 Medical Device |