The following data is part of a premarket notification filed by Integrated Surgical Systems, Inc. with the FDA for Digimatch Robodoc Surgical System.
| Device ID | K072629 |
| 510k Number | K072629 |
| Device Name: | DIGIMATCH ROBODOC SURGICAL SYSTEM |
| Classification | Orthopedic Computer Controlled Surgical System |
| Applicant | INTEGRATED SURGICAL SYSTEMS, INC. 1433 N. MARKET BLVD., #1 Sacremento, CA 95834 |
| Contact | Russ Hibbert |
| Correspondent | Russ Hibbert INTEGRATED SURGICAL SYSTEMS, INC. 1433 N. MARKET BLVD., #1 Sacremento, CA 95834 |
| Product Code | OJP |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-17 |
| Decision Date | 2008-08-06 |
| Summary: | summary |