Molded Polysulfone Trial Prosthesis
FDA 510(k) K811205 · Shannon Group
510(k) numberK811205
Submission
- Device name
- Molded Polysulfone Trial Prosthesis
- Applicant
- Shannon Group
Mchenry, IL, US - Received
- May 1, 1981
- Decision date
- May 21, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HWT – Template
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4800
- Specialty
- Orthopedic
Other 510(k)s with product code HWT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974406 | OrthoplanHWT · Traditional | Ortho-Graphics, Inc. | 02/18/1998SE |
| K960685 | Orthodoc Preoperative Planner Model 500HWT · Traditional | Integrated Surgical Systems, Inc. | 01/17/1997SE |
| K894228 | Kronner Spherical CuttersHWT · Traditional | Kronner Medical | 07/23/1990SE |
| K870843 | Schultz Phalangeal Comp Trial/Metacarpal Comp TriaHWT · Traditional | Warsaw Orthopedic, Inc. | 05/27/1987SE |
| K871323 | Arthroscopic Meniscal Suture SystemHWT · Traditional | Orthopedic Systems, Inc. | 05/01/1987SE |
| K830360 | 3M Osteotomy GuideHWT · Traditional | 3M Company | 03/01/1983SE |
| K781091 | Knee Instrumentation, CondylarHWT · Traditional | Biomet, Inc. | 07/17/1978SE |
| K771710 | Worrell Patella TemplateHWT · Traditional | Depuy, Inc. | 10/06/1977SE |
| K771709 | Worrell Trial PatellaHWT · Traditional | Depuy, Inc. | 10/06/1977SE |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K820156 | Their Electro Surgical Coutery PencilGEI · Traditional | 02/18/1982SE |
Questions and answers
When was Molded Polysulfone Trial Prosthesis cleared by the FDA?
Molded Polysulfone Trial Prosthesis (K811205) received a 510(k) decision of Substantially Equivalent on May 21, 1981, 20 days after the submission was received.
What is the product code of K811205?
The FDA product code is HWT – Template, a Class I (low risk) device regulated under 21 CFR 888.4800.