The following data is part of a premarket notification filed by Genossis, Llc with the FDA for Optossol Compression Device System.
| Device ID | K140875 |
| 510k Number | K140875 |
| Device Name: | OPTOSSOL COMPRESSION DEVICE SYSTEM |
| Classification | Pin, Fixation, Threaded |
| Applicant | GENOSSIS, LLC 29 WATER STREET, SUITE 305 Newburyport, MA 01950 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands GENOSSIS, LLC 29 WATER STREET, SUITE 305 Newburyport, MA 01950 |
| Product Code | JDW |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-04 |
| Decision Date | 2014-05-30 |
| Summary: | summary |