Osi Rizzoli Trauma Table (Electric Version)
FDA 510(k) K881060 · Orthopedic Systems, Inc.
510(k) numberK881060
Submission
- Device name
- Osi Rizzoli Trauma Table (Electric Version)
- Applicant
- Orthopedic Systems, Inc.
Hayward, CA, US - Received
- March 4, 1988
- Decision date
- March 25, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4960
- Specialty
- General, Plastic Surgery
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| K894789 | Dmi 250 Series Power Surgery TableJEA · Traditional | M.D. Intl., Inc. | 08/29/1989SE |
| K874762 | Arthrotract Upper Limb Traction AccessoryJEA · Traditional | Andronic Devices, Ltd. | 12/10/1987SE |
| K873080 | Arthrobot 101 Upper Limb Traction AccessoryJEA · Traditional | Andronic Devices, Ltd. | 11/25/1987SE |
| K873079 | Arthrobot 100 Upper Limb PositionerJEA · Traditional | Andronic Devices, Ltd. | 11/25/1987SE |
More from Andronic Devices, Ltd.
| 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 Trauma Table (Electric Version) cleared by the FDA?
Osi Rizzoli Trauma Table (Electric Version) (K881060) received a 510(k) decision of Substantially Equivalent on March 25, 1988, 21 days after the submission was received.
What is the product code of K881060?
The FDA product code is JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.