The following data is part of a premarket notification filed by Integrated Surgical Systems, Inc. with the FDA for Orthodoc Preoperative Planner Model 500.
| Device ID | K960685 |
| 510k Number | K960685 |
| Device Name: | ORTHODOC PREOPERATIVE PLANNER MODEL 500 |
| Classification | Template |
| Applicant | INTEGRATED SURGICAL SYSTEMS, INC. 829 WEST STADIUM LN. Sacramento, CA 95834 |
| Contact | Robert Van Osdel |
| Correspondent | Robert Van Osdel INTEGRATED SURGICAL SYSTEMS, INC. 829 WEST STADIUM LN. Sacramento, CA 95834 |
| Product Code | HWT |
| CFR Regulation Number | 888.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-20 |
| Decision Date | 1997-01-17 |
| Summary: | summary |