The following data is part of a premarket notification filed by Interbody Innovations, Llp with the FDA for Peek Spinal Spheres.
| Device ID | K073105 |
| 510k Number | K073105 |
| Device Name: | PEEK 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-02 |
| Decision Date | 2008-01-03 |
| Summary: | summary |