The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Roc Lumbar Plating System.
| Device ID | K090228 |
| 510k Number | K090228 |
| Device Name: | ROC LUMBAR PLATING SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Contact | Karla Schaffner |
| Correspondent | Karla Schaffner ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-30 |
| Decision Date | 2009-04-29 |
| Summary: | summary |