| Device Type ID | 4695 |
| Device Name | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HSZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4695 |
| Device | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Product Code | HSZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| CFR Regulation Number | 878.4820 [🔎] |
| Device Problems | |
|---|---|
Material Rupture | 12 |
Air Leak | 10 |
Break | 8 |
Device Operates Differently Than Expected | 3 |
Device Inoperable | 2 |
Use Of Device Problem | 2 |
Detachment Of Device Component | 2 |
Leak / Splash | 1 |
Mechanical Jam | 1 |
Fluid Leak | 1 |
Mechanical Problem | 1 |
Overheating Of Device | 1 |
Insufficient Information | 1 |
Noise, Audible | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Hose | 1 |
Disassembly | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Vibration | 1 |
Defective Component | 1 |
Fracture | 1 |
| Total Device Problems | 53 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | The Anspach Effort, Inc. | II | May-04-2017 |
| 2 | The Anspach Effort, Inc. | II | Jul-03-2014 |
| 3 | The Anspach Effort, Inc. | II | Jan-09-2014 |