The following data is part of a premarket notification filed by Biomet Spine Llc, with the FDA for Polaris Spinal System - Ha Coated.
| Device ID | K141804 |
| 510k Number | K141804 |
| Device Name: | POLARIS SPINAL SYSTEM - HA COATED |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | BIOMET SPINE LLC, 310 Interlocken Pkwy Ste 120 Broomfield, CO 80021 |
| Contact | Kimberly Mccoy |
| Correspondent | Kimberly Mccoy BIOMET SPINE LLC, 310 Interlocken Pkwy Ste 120 Broomfield, CO 80021 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-03 |
| Decision Date | 2014-09-25 |
| Summary: | summary |