JEB
13 FDA 510(k) clearances · Product code
31 daysmedian time to decision
68 days90th percentile
13clearances measured
FDA profile
- Official device name
- Table, Surgical With Orthopedic Accessories, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2006: 2 · 2007: 3 · 2009: 5 · 2010: 10 · 2011: 10 · 2013: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ORTHOVISION TABLE (K905816) | American Sterilizer Co. | 1991-03-06 |
| SCHOLTEN FRAME (K900405) | Scholten Surgical Instruments, Inc. | 1990-03-01 |
| ORTHO-J, INC. BEK-JS-004 (K891917) | Ortho-J, Inc. | 1989-05-26 |
| WILLIAMS BELT & BOOT (K891387) | Arthro-Medic, Inc. | 1989-05-23 |
| K ORTHOPEDIC TABLE (K881101) | Instrumentation Specialties, Inc. | 1988-04-06 |
| OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION (K880263) | Orthopedic Systems, Inc. | 1988-03-15 |
| PLASTER TABLE 1418 (K873274) | Stierlen-Maquet AG | 1987-09-17 |
| EXTENSION DEVICE 1416 (K873276) | Stierlen-Maquet AG | 1987-09-17 |
| EXTENSION TABLE 1417 (K873275) | Stierlen-Maquet AG | 1987-09-17 |
| ORTHOPAEDIC TABLE 1420 (K873273) | Stierlen-Maquet AG | 1987-09-17 |
| CAST BLOCK (K781082) | Orthopedic Equipment Co., Inc. | 1978-07-07 |
| ARTHROSTRESS (K772321) | Mtd, Inc. | 1978-01-03 |
| SPINAL SURGERY FRAME (K771020) | Orthopedic Systems, Inc. | 1977-06-17 |
Track JEB automatically
Every clearance here is in the API, with alerts when new ones post.