The following data is part of a premarket notification filed by Syntorr Inc with the FDA for Syntorr K-wire And Pin System.
| Device ID | K161489 |
| 510k Number | K161489 |
| Device Name: | Syntorr K-wire And Pin System |
| Classification | Pin, Fixation, Smooth |
| Applicant | SYNTORR INC 1157 HARKER AVENUE Palo Alto, CA 94301 |
| Contact | Daniel Martin |
| Correspondent | Samuel Pollard MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS, LLC 1331 H Street NW, 12th Floor Washington, DC 20005 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2016-09-16 |
| Summary: | summary |