The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Spiral Radius 90-d Sst System.
| Device ID | K012273 |
| 510k Number | K012273 |
| Device Name: | SPIRAL RADIUS 90-D SST SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Jennifer Schuck |
| Correspondent | Jennifer Schuck 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 |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-19 |
| Decision Date | 2001-08-15 |
| Summary: | summary |