The following data is part of a premarket notification filed by Interbody Innovations Llp with the FDA for Spinal Spheres.
| Device ID | K062992 |
| 510k Number | K062992 |
| Device Name: | SPINAL SPHERES |
| Classification | Intervertebral Fusion Device With Bone Graft, Solid-sphere, Lumbar |
| Applicant | INTERBODY INNOVATIONS LLP 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J D Webb |
| Correspondent | J D Webb INTERBODY INNOVATIONS LLP 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| 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 | 2006-10-02 |
| Decision Date | 2007-07-27 |
| Summary: | summary |