Device Type ID | 3660 |
Device Name | Punch, Skull |
Regulation Description | Skull Punch. |
Regulation Medical Specialty | Neurology |
Review Panel | Neurology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 882.4750 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | GXJ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3660 |
Device | Punch, Skull |
Product Code | GXJ |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Skull Punch. |
CFR Regulation Number | 882.4750 [🔎] |
Device Problems | |
---|---|
Break | 3 |
Fracture | 1 |
Device Operates Differently Than Expected | 1 |
Total Device Problems | 5 |