The following data is part of a premarket notification filed by Trinity Orthopedics, Llc with the FDA for Modification To Single Planar Multi Axis (spma) Pedicle Screw System.
| Device ID | K081790 |
| 510k Number | K081790 |
| Device Name: | MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | TRINITY ORTHOPEDICS, LLC 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Kevin A Thomas |
| Correspondent | Kevin A Thomas TRINITY ORTHOPEDICS, LLC 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-25 |
| Decision Date | 2008-07-24 |
| Summary: | summary |