The following data is part of a premarket notification filed by Alphatec/nexmed with the FDA for Roc Lumbar Plating System.
| Device ID | K050078 |
| 510k Number | K050078 |
| Device Name: | ROC LUMBAR PLATING SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ALPHATEC/NEXMED 6110 CORTE DEL CEDRO Carlsbad, CA 92009 |
| Contact | Ellen A Yarnall |
| Correspondent | Ellen A Yarnall ALPHATEC/NEXMED 6110 CORTE DEL CEDRO Carlsbad, CA 92009 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-13 |
| Decision Date | 2005-02-18 |
| Summary: | summary |