The following data is part of a premarket notification filed by Trinity Orthopedics, Llc with the FDA for Single Planar Multi Axial (spma) Pedicle Screw System.
| Device ID | K070295 |
| 510k Number | K070295 |
| Device Name: | SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | TRINITY ORTHOPEDICS, LLC 11234 EL CAMINO REAL, SUITE 20 San Diego,, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson TRINITY ORTHOPEDICS, LLC 11234 EL CAMINO REAL, SUITE 20 San Diego,, CA 92130 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-31 |
| Decision Date | 2007-05-21 |
| Summary: | summary |