Osi Rizzoli Orthopedic Table/Manual Version
FDA 510(k) K880263 · Orthopedic Systems, Inc.
510(k) numberK880263
Submission
- Device name
- Osi Rizzoli Orthopedic Table/Manual Version
- Applicant
- Orthopedic Systems, Inc.
Hayward, CA, US - Received
- January 22, 1988
- Decision date
- March 15, 1988
- 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 |
| K891917 | Ortho-J, Inc. BEK-JS-004JEB · Traditional | Ortho-J, Inc. | 05/26/1989SE |
| K891387 | Williams Belt & BootJEB · Traditional | Arthro-Medic, Inc. | 05/23/1989SE |
| K881101 | K Orthopedic TableJEB · Traditional | Instrumentation Specialties, Inc. | 04/06/1988SE |
| 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 |
More from Orthopedic Equipment Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K952495 | Anchors Away Soft Tissue Attachment SystemLXH · Traditional | 01/22/1996SE |
| K920256 | Spine Motion Analyzer with EmgKQX · Traditional | 08/10/1992SE |
| K910736 | Jackson Multipurpose Operating TableJEA · Traditional | 05/21/1991SE |
| K910031 | Park City Shoulder PositionerFWZ · Traditional | 01/24/1991SE |
| K903938 | C Fit CupJDI · Traditional | 01/04/1991SN |
| K892503 | Nuffield Total KneeJWH · Traditional | 05/04/1990SN |
| K896678 | Silicone PlugHRX · Traditional | 01/30/1990SE |
| K894283 | Comprehensive Spine Motion AnalyzerKQX · Traditional | 01/19/1990SE |
| K890498 | Freeman Modular Hip Stem Ridged VersionJDI · Traditional | 10/13/1989SN |
| K890331 | Freeman Total Hip System Ridged StemLWJ · Traditional | 10/13/1989SE |
Questions and answers
When was Osi Rizzoli Orthopedic Table/Manual Version cleared by the FDA?
Osi Rizzoli Orthopedic Table/Manual Version (K880263) received a 510(k) decision of Substantially Equivalent on March 15, 1988, 53 days after the submission was received.
What is the product code of K880263?
The FDA product code is JEB – Table, Surgical With Orthopedic Accessories, Manual, a Class I (low risk) device regulated under 21 CFR 878.4950.