The following data is part of a premarket notification filed by G Surgical, Llc with the FDA for Gps Spacers.
| Device ID | K142456 |
| 510k Number | K142456 |
| Device Name: | GPS Spacers |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | G SURGICAL, LLC 5757 Central Ave, Suite G Boulder, CO 80301 |
| Contact | Donald Grafton |
| Correspondent | Karen E Warden, Ph.d BACKROADS CONSULTING, INC. P.O. BOX 566 Chesterland, OH 44026 -2141 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-02 |
| Decision Date | 2015-04-10 |
| Summary: | summary |