The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Aurora Titanium Spinal Rod System.
| Device ID | K974213 |
| 510k Number | K974213 |
| Device Name: | AURORA TITANIUM SPINAL ROD SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Sharon Murphy |
| Correspondent | Sharon Murphy UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-10 |
| Decision Date | 1998-02-04 |
| Summary: | summary |