Device Type ID | 5692 |
Device Name | Table, Surgical With Orthopedic Accessories, Manual |
Regulation Description | Manual Operating Table And Accessories And Manual Operating Chair And Accessories. |
Regulation Medical Specialty | General & Plastic Surgery |
Review Panel | General & Plastic Surgery |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 878.4950 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | JEB |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5692 |
Device | Table, Surgical With Orthopedic Accessories, Manual |
Product Code | JEB |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Manual Operating Table And Accessories And Manual Operating Chair And Accessories. |
CFR Regulation Number | 878.4950 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Allen Medical Systems | II | Feb-20-2018 |
2 | Schaerer Medical USA Inc | II | Nov-08-2016 |
3 | Zimmer Biomet, Inc. | II | Feb-28-2018 |