The following data is part of a premarket notification filed by Oratec Interventions, Inc. with the FDA for Ora-50 S Autotemp Electrothermal Spine System And Accessories.
| Device ID | K993854 |
| 510k Number | K993854 |
| Device Name: | ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, CA 94025 |
| Contact | Shiela Ramerman |
| Correspondent | Shiela Ramerman ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, CA 94025 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-15 |
| Decision Date | 1999-12-06 |
| Summary: | summary |