The following data is part of a premarket notification filed by Stryker Spine with the FDA for Modification To:radius Spinal System.
| Device ID | K101144 |
| 510k Number | K101144 |
| Device Name: | MODIFICATION TO:RADIUS SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Curtis Truesdale |
| Correspondent | Curtis Truesdale STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-23 |
| Decision Date | 2010-07-08 |
| Summary: | summary |