The following data is part of a premarket notification filed by Biomet Spine with the FDA for Synergy Spinal System (6.35 Polaris).
| Device ID | K081952 |
| 510k Number | K081952 |
| Device Name: | SYNERGY SPINAL SYSTEM (6.35 POLARIS) |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | BIOMET SPINE 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly BIOMET SPINE 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-09 |
| Decision Date | 2008-10-07 |
| Summary: | summary |