| Device Type ID | 3700 |
| Device Name | Tong, Skull For Traction |
| Regulation Description | Skull Tongs For Traction. |
| 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) |
| CFR Regulation Number | 882.5960 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HAX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3700 |
| Device | Tong, Skull For Traction |
| Product Code | HAX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Skull Tongs For Traction. |
| CFR Regulation Number | 882.5960 [🔎] |
| Device Problems | |
|---|---|
Fluid Leak | 1 |
| Total Device Problems | 1 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Instrumed International, Inc. | II | Dec-16-2014 |
| 2 | Ossur Americas | II | Mar-11-2019 |