The following data is part of a premarket notification filed by Via Surgical Ltd. with the FDA for Fastouch Fixation System.
| Device ID | K162252 |
| 510k Number | K162252 |
| Device Name: | FasTouch Fixation System |
| Classification | Staple, Implantable |
| Applicant | VIA SURGICAL LTD. MITZPE KINERET STREET 22/1 Moshav Amirim, IL 20115 |
| Contact | Ofek Levin |
| Correspondent | Leo Basta NORTHSTAR BIOMEDICAL ASSOCIATES 93 BENEFIT STREET Providence, RI 02904 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-10 |
| Decision Date | 2016-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290017155118 | K162252 | 000 |
| 07290017155104 | K162252 | 000 |
| 17290017155040 | K162252 | 000 |
| 17290017155019 | K162252 | 000 |