Orthodoc Preoperative Planner Model 500
FDA 510(k) K960685 · Integrated Surgical Systems, Inc.
510(k) numberK960685
Submission
- Device name
- Orthodoc Preoperative Planner Model 500
- Applicant
- Integrated Surgical Systems, Inc.
Sacramento, CA, US - Received
- February 20, 1996
- Decision date
- January 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWT – Template
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4800
- Specialty
- Orthopedic
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| 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 |
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Questions and answers
When was Orthodoc Preoperative Planner Model 500 cleared by the FDA?
Orthodoc Preoperative Planner Model 500 (K960685) received a 510(k) decision of Substantially Equivalent on January 17, 1997, 332 days after the submission was received.
What is the product code of K960685?
The FDA product code is HWT – Template, a Class I (low risk) device regulated under 21 CFR 888.4800.