Cast Block
FDA 510(k) K781082 · Orthopedic Equipment Co., Inc.
510(k) numberK781082
Submission
- Device name
- Cast Block
- Applicant
- Orthopedic Equipment Co., Inc.
Mchenry, IL, US - Received
- June 29, 1978
- Decision date
- July 7, 1978
- 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 |
| 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 |
More from Stierlen-Maquet AG
| 510(k) | Device | Decision |
|---|---|---|
| K834035 | Universal Self-Aligning Acetabular ComJDI · Traditional | 06/19/1984SE |
| K841189 | Oec/Rezaian Spinal FixatorKWQ · Traditional | 05/16/1984SE |
| K800530 | Schlein Tri-Surface AnkleHSN · Traditional | 04/02/1980SE |
| K781445 | SpreaderGAD · Traditional | 09/27/1979SE |
| K790247 | Tourniquet Test Gage · Traditional | 02/26/1979SE |
| K790209 | Filter System, Altner DisposableGAZ · Traditional | 02/26/1979SE |
| K781451 | Flat WrenchHXS · Traditional | 09/27/1978SE |
| K781450 | DriversGFC · Traditional | 09/27/1978SE |
| K781449 | Harrington Spinal ElevatorGEG · Traditional | 09/27/1978SE |
| K781448 | Harrington Hook ClampGEN · Traditional | 09/27/1978SE |
Questions and answers
When was Cast Block cleared by the FDA?
Cast Block (K781082) received a 510(k) decision of Substantially Equivalent on July 7, 1978, 8 days after the submission was received.
What is the product code of K781082?
The FDA product code is JEB – Table, Surgical With Orthopedic Accessories, Manual, a Class I (low risk) device regulated under 21 CFR 878.4950.