The following data is part of a premarket notification filed by Acumed Llc with the FDA for Polarus Connect.
| Device ID | K131636 |
| 510k Number | K131636 |
| Device Name: | POLARUS CONNECT |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Contact | Brittany Cunningham |
| Correspondent | Brittany Cunningham ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Product Code | LXT |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HSB |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-04 |
| Decision Date | 2013-10-10 |
| Summary: | summary |