3M Osteotomy Guide
FDA 510(k) K830360 · 3M Company
510(k) numberK830360
Submission
- Device name
- 3M Osteotomy Guide
- Applicant
- 3M Company
White City, OR, US - Received
- February 3, 1983
- Decision date
- March 1, 1983
- 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
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| 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 |
| 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 |
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Questions and answers
When was 3M Osteotomy Guide cleared by the FDA?
3M Osteotomy Guide (K830360) received a 510(k) decision of Substantially Equivalent on March 1, 1983, 26 days after the submission was received.
What is the product code of K830360?
The FDA product code is HWT – Template, a Class I (low risk) device regulated under 21 CFR 888.4800.