Orthoplan
FDA 510(k) K974406 · Ortho-Graphics, Inc.
510(k) numberK974406
Submission
- Device name
- Orthoplan
- Applicant
- Ortho-Graphics, Inc.
Saltlake, UT, US - Received
- November 21, 1997
- Decision date
- February 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| 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 |
Questions and answers
When was Orthoplan cleared by the FDA?
Orthoplan (K974406) received a 510(k) decision of Substantially Equivalent on February 18, 1998, 89 days after the submission was received.
What is the product code of K974406?
The FDA product code is HWT – Template, a Class I (low risk) device regulated under 21 CFR 888.4800.