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 |