The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Rf Intradiscal Adaptor, Model 406-750.
| Device ID | K063480 |
| 510k Number | K063480 |
| Device Name: | STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Jean Sheppard |
| Correspondent | Jean Sheppard STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-17 |
| Decision Date | 2007-05-22 |
| Summary: | summary |