The following data is part of a premarket notification filed by Pinnacle Spine Group with the FDA for Pgs 5.5 Mm Cannulated Pedicle Screw.
| Device ID | K141282 |
| 510k Number | K141282 |
| Device Name: | PGS 5.5 MM CANNULATED PEDICLE SCREW |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | PINNACLE SPINE GROUP 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Contact | Meredith May |
| Correspondent | Meredith May PINNACLE SPINE GROUP 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-16 |
| Decision Date | 2014-12-02 |
| Summary: | summary |