Ortho-J, Inc. BEK-JS-004
FDA 510(k) K891917 · Ortho-J, Inc.
510(k) numberK891917
Submission
- Device name
- Ortho-J, Inc. BEK-JS-004
- Applicant
- Ortho-J, Inc.
Tifton, GA, US - Received
- March 27, 1989
- Decision date
- May 26, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JEB – Table, Surgical With Orthopedic Accessories, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code JEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K905816 | Orthovision TableJEB · Traditional | American Sterilizer Co. | 03/06/1991SE |
| K900405 | Scholten FrameJEB · Traditional | Scholten Surgical Instruments, Inc. | 03/01/1990SE |
| K891387 | Williams Belt & BootJEB · Traditional | Arthro-Medic, Inc. | 05/23/1989SE |
| K881101 | K Orthopedic TableJEB · Traditional | Instrumentation Specialties, Inc. | 04/06/1988SE |
| K880263 | Osi Rizzoli Orthopedic Table/Manual VersionJEB · Traditional | Orthopedic Systems, Inc. | 03/15/1988SE |
| K873276 | Extension Device 1416JEB · Traditional | Stierlen-Maquet AG | 09/17/1987SE |
| K873275 | Extension Table 1417JEB · Traditional | Stierlen-Maquet AG | 09/17/1987SE |
| K873274 | Plaster Table 1418JEB · Traditional | Stierlen-Maquet AG | 09/17/1987SE |
| K873273 | Orthopaedic Table 1420JEB · Traditional | Stierlen-Maquet AG | 09/17/1987SE |
| K781082 | Cast BlockJEB · Traditional | Orthopedic Equipment Co., Inc. | 07/07/1978SE |
Questions and answers
When was Ortho-J, Inc. BEK-JS-004 cleared by the FDA?
Ortho-J, Inc. BEK-JS-004 (K891917) received a 510(k) decision of Substantially Equivalent on May 26, 1989, 60 days after the submission was received.
What is the product code of K891917?
The FDA product code is JEB – Table, Surgical With Orthopedic Accessories, Manual, a Class I (low risk) device regulated under 21 CFR 878.4950.