The following data is part of a premarket notification filed by Via Surgical Ltd. with the FDA for Fastouch Absorbable Fixation System.
| Device ID | K181668 |
| 510k Number | K181668 |
| Device Name: | FasTouch Absorbable Fixation System |
| Classification | Staple, Implantable |
| Applicant | Via Surgical Ltd. Mitzpe Kineret Street 22/1 Moshav Amirim, IL 2011500 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-25 |
| Decision Date | 2019-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290017155286 | K181668 | 000 |
| 17290017155279 | K181668 | 000 |
| 17290017155248 | K181668 | 000 |
| 17290017155217 | K181668 | 000 |