JEBClass I
Table, Surgical With Orthopedic Accessories, Manual
21 CFR 878.4950 / General, Plastic Surgery
JEB is the FDA product code for Table, Surgical With Orthopedic Accessories, Manual, a class I device type, regulated under 21 CFR 878.4950. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 11 recalls.
Classification record
- Product code
- JEB
- Device name
- Table, Surgical With Orthopedic Accessories, Manual
- Regulation
- 21 CFR 878.4950
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 13
- Ingested recalls
- 11
Clearances, product code JEB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 2 |
| 1987 | 4 |
| 1988 | 2 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 1 |
Applicants with the most clearances
Product code JEB| Applicant | Clearances |
|---|---|
| Stierlen-Maquet AG | 4 |
| Mizuho Orthopedic Systems Inc | 2 |
| American Sterilizer Co. | 1 |
| Arthro-Medic, Inc. | 1 |
| Instrumentation Specialties, Inc. | 1 |
| Mtd, Inc. | 1 |
| Ortho-J, Inc. | 1 |
| Orthopedic Equipment Co., Inc. | 1 |
| Scholten Surgical Instruments, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- A.M. Surgical, Inc.
- Accurate Surgical & Scientific Instruments Corp.
- American Benchmark Machine Works
- Amplitude
- Arthro-Positioning Systems LLC
- Artisan Medical
- Aspen Surgical Products, Inc.
- B & J Medical LLC
- Chengdu Ruinuo Meijer Medical Instrument Co., Ltd.
- Convertors de Mexico S. de R.L. de C.V
- DePuy Mitek, Inc.
- Depuy Orthopaedics Inc.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
