The following data is part of a premarket notification filed by Via Surgical Ltd. with the FDA for Fastouch Fixation System.
| Device ID | K132698 |
| 510k Number | K132698 |
| Device Name: | FASTOUCH FIXATION SYSTEM |
| Classification | Staple, Implantable |
| Applicant | VIA SURGICAL LTD. 93 BENEFIT ST. Providence, RI 02904 |
| Contact | Leo Basta |
| Correspondent | Leo Basta VIA SURGICAL LTD. 93 BENEFIT ST. Providence, RI 02904 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-29 |
| Decision Date | 2014-03-14 |
| Summary: | summary |