The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Polarus Cap Screw.
| Device ID | K013616 |
| 510k Number | K013616 |
| Device Name: | POLARUS CAP SCREW |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Contact | Shari Jeffers |
| Correspondent | Shari Jeffers ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-05 |
| Decision Date | 2001-12-19 |
| Summary: | summary |