The following data is part of a premarket notification filed by General Surgical Innovations with the FDA for Fixation System.
| Device ID | K983318 |
| 510k Number | K983318 |
| Device Name: | FIXATION SYSTEM |
| Classification | Staple, Implantable |
| Applicant | GENERAL SURGICAL INNOVATIONS 10460 BUBB RD. Cupertino, CA 95014 |
| Contact | Ferolyn T Powell |
| Correspondent | Ferolyn T Powell GENERAL SURGICAL INNOVATIONS 10460 BUBB RD. Cupertino, CA 95014 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-21 |
| Decision Date | 1999-03-01 |
| Summary: | summary |