The following data is part of a premarket notification filed by United States Surgical with the FDA for Modification To Spiral Radius 90-d Sst System.
| Device ID | K021825 |
| 510k Number | K021825 |
| Device Name: | MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | UNITED STATES SURGICAL 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Tina Rideout |
| Correspondent | Tina Rideout UNITED STATES SURGICAL 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-04 |
| Decision Date | 2002-07-01 |
| Summary: | summary |