The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Surgical Dynamics Rodding System (previously Known As The Aurora Titanium Spinal Rod System).
| Device ID | K983197 |
| 510k Number | K983197 |
| Device Name: | SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM) |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Sharon L Murphy |
| Correspondent | Sharon L Murphy UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-11 |
| Decision Date | 1998-10-26 |
| Summary: | summary |