The following data is part of a premarket notification filed by Synergetics, Inc. with the FDA for Stryker Intradiscal Rf Generator.
| Device ID | K063489 |
| 510k Number | K063489 |
| Device Name: | STRYKER INTRADISCAL RF GENERATOR |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | SYNERGETICS, INC. 3600 HORIZON DRIVE Valley Forge, PA 19406 |
| Contact | Dan Regan |
| Correspondent | Dan Regan SYNERGETICS, INC. 3600 HORIZON DRIVE Valley Forge, PA 19406 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-17 |
| Decision Date | 2007-05-23 |
| Summary: | summary |