The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Spine Power Adaptor (accessory Instrument).
| Device ID | K111478 |
| 510k Number | K111478 |
| Device Name: | STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT) |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Tiffani Rogers |
| Correspondent | Tiffani Rogers STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | NKB |
| 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 | 2011-05-27 |
| Decision Date | 2011-08-04 |
| Summary: | summary |