FDA product code JEB: Table, Surgical With Orthopedic Accessories, Manual
JEB is the FDA product code for table, surgical with orthopedic accessories, manual. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel. FDA has cleared 13 510(k) submissions under JEB, from 9 different applicants. The average 510(k) review took 36 days (median 31). FDA has posted 11 recalls for JEB devices.
Classification
| Field | Value |
|---|---|
| Device name | Table, Surgical With Orthopedic Accessories, Manual |
| Device class | Class I |
| Regulation | 21 CFR 878.4950 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JEB clearance
Top JEB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stierlen-Maquet AG | 4 | 1987-09-17 |
| Orthopedic Systems, Inc. | 2 | 1988-03-15 |
| American Sterilizer Co. | 1 | 1991-03-06 |
| Scholten Surgical Instruments, Inc. | 1 | 1990-03-01 |
| Ortho-J, Inc. | 1 | 1989-05-26 |
4 more applicants have JEB clearances. See the full list in Caduvo.
Most recent JEB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K905816 | American Sterilizer Co. | ORTHOVISION TABLE | 1991-03-06 | 68 |
| K900405 | Scholten Surgical Instruments, Inc. | SCHOLTEN FRAME | 1990-03-01 | 31 |
| K891917 | Ortho-J, Inc. | ORTHO-J, INC. BEK-JS-004 | 1989-05-26 | 60 |
| K891387 | Arthro-Medic, Inc. | WILLIAMS BELT & BOOT | 1989-05-23 | 70 |
| K881101 | Instrumentation Specialties, Inc. | K ORTHOPEDIC TABLE | 1988-04-06 | 22 |
Recalls for JEB devices
11 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-04-16.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code JEB?
JEB is the FDA product code for table, surgical with orthopedic accessories, manual. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel.
What device class is JEB?
Class I, regulation 21 CFR 878.4950. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JEB?
Across 13 cleared submissions the average was 36 days from receipt to decision (median 31).
Which companies have the most JEB clearances?
Stierlen-Maquet AG (4); Orthopedic Systems, Inc. (2); American Sterilizer Co. (1); Scholten Surgical Instruments, Inc. (1); Ortho-J, Inc. (1).
Have JEB devices been recalled?
Yes: 11 product recalls across 7 recall events; the most recent began 2019-04-16.
Next steps
- Run an FDA pathway report with predicate devices for product code JEB
- Run a recall and safety report across every JEB manufacturer
- Watch product code JEB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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