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 Rodding System.
| Device ID | K000009 |
| 510k Number | K000009 |
| Device Name: | SPIRAL RADIUS RODDING SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Luis Nesprido |
| Correspondent | Luis Nesprido UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | KWQ |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-03 |
| Decision Date | 2000-03-10 |