The following data is part of a premarket notification filed by Acu-med, Inc. with the FDA for Tentatively Polarus Ex Rod.
| Device ID | K952534 |
| 510k Number | K952534 |
| Device Name: | TENTATIVELY POLARUS EX ROD |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ACU-MED, INC. 10950 SW 5TH, SUITE 170 Beaveton, OR 97005 |
| Contact | Shari L Jeffers |
| Correspondent | Shari L Jeffers ACU-MED, INC. 10950 SW 5TH, SUITE 170 Beaveton, 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 | 1995-06-01 |
| Decision Date | 1995-07-13 |