The following data is part of a premarket notification filed by New Era Orthopedics, Llc with the FDA for Polyscrew Pedicle Screw System.
| Device ID | K150647 |
| 510k Number | K150647 |
| Device Name: | Polyscrew Pedicle Screw System |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | New Era Orthopedics, LLC 1214 Research Boulevard, Suite 1019 Hummelstown, PA 17036 |
| Contact | Mark De Baca |
| Correspondent | Kenneth C Maxwell Ii Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-12 |
| Decision Date | 2015-04-08 |
| Summary: | summary |