Kronner Spherical Cutters
FDA 510(k) K894228 · Kronner Medical
510(k) numberK894228
Submission
- Device name
- Kronner Spherical Cutters
- Applicant
- Kronner Medical
Roseburg, OR, US - Received
- June 19, 1989
- Decision date
- July 23, 1990
- 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 |
| 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 |
| K811205 | Molded Polysulfone Trial ProsthesisHWT · Traditional | Shannon Group | 05/21/1981SE |
| 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 |
|---|---|---|
| K895171 | Blood Gas Safety SyringeCBT · Traditional | 11/07/1989SE |
| K895173 | Skeletal Fixation PinJDW · Traditional | 09/12/1989SE |
| K895172 | Kronner Sacral Pin GuideLXH · Traditional | 09/12/1989SE |
| K871248 | Kronner Colles-Forearm External FixationKTT · Traditional | 06/03/1987SE |
| K871249 | Kronner Bi-Planer Tibia External FixationKTT · Traditional | 05/22/1987SE |
| K871247 | Kronner Universal Frame External FixationKTT · Traditional | 05/22/1987SE |
Questions and answers
When was Kronner Spherical Cutters cleared by the FDA?
Kronner Spherical Cutters (K894228) received a 510(k) decision of Substantially Equivalent on July 23, 1990, 399 days after the submission was received.
What is the product code of K894228?
The FDA product code is HWT – Template, a Class I (low risk) device regulated under 21 CFR 888.4800.