The following data is part of a premarket notification filed by Biomet Spine with the FDA for Spinal Stabilizing Sphere System.
| Device ID | K063139 |
| 510k Number | K063139 |
| Device Name: | SPINAL STABILIZING SPHERE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Solid-sphere, Lumbar |
| Applicant | BIOMET SPINE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET SPINE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | NVR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-16 |
| Decision Date | 2007-04-04 |
| Summary: | summary |