The following data is part of a premarket notification filed by Johnson & Johnson with the FDA for Expedium Spine System, Moss Miami Spine System.
| Device ID | K103490 |
| 510k Number | K103490 |
| Device Name: | EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | JOHNSON & JOHNSON 325 PARAMOUNT DR. Raynham, MA 02767 -0151 |
| Contact | Kevin Stevens |
| Correspondent | Kevin Stevens JOHNSON & JOHNSON 325 PARAMOUNT DR. Raynham, MA 02767 -0151 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| 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 | 2010-11-26 |
| Decision Date | 2011-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034266848 | K103490 | 000 |