The following data is part of a premarket notification filed by Eisertech, Llc with the FDA for Temporary Fixation Pins.
| Device ID | K192768 |
| 510k Number | K192768 |
| Device Name: | Temporary Fixation Pins |
| Classification | Pin, Fixation, Threaded |
| Applicant | EiserTech, LLC 9988 Hibert Street Suite 302 San Diego, CA 32131 |
| Contact | Lukas Eisermann |
| Correspondent | Dawn Norman MRC-X, LLC 6075 Poplar Ave Memphis, TN 38119 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-12-26 |
| Summary: | summary |