The following data is part of a premarket notification filed by Biomet Spine with the FDA for Polaris Be Rods.
| Device ID | K071377 |
| 510k Number | K071377 |
| Device Name: | POLARIS BE RODS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | BIOMET SPINE 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Contact | Debra Bing |
| Correspondent | Debra Bing BIOMET SPINE 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-17 |
| Decision Date | 2007-08-06 |
| Summary: | summary |