The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Roc Lumbar System.
| Device ID | K063668 |
| 510k Number | K063668 |
| Device Name: | ROC LUMBAR SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad, CA 92011 |
| Contact | Paula Morgan |
| Correspondent | Paula Morgan ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad, CA 92011 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-11 |
| Decision Date | 2007-05-18 |
| Summary: | summary |