The following data is part of a premarket notification filed by Medtronic Surgical Technologies with the FDA for Triton Electric High Torque Handpiece And Software Module.
| Device ID | K121264 |
| 510k Number | K121264 |
| Device Name: | TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | MEDTRONIC SURGICAL TECHNOLOGIES 4620 NORTH BEACH STREET Fort Worth, TX 76137 |
| Contact | Rishi Sinha |
| Correspondent | Rishi Sinha MEDTRONIC SURGICAL TECHNOLOGIES 4620 NORTH BEACH STREET Fort Worth, TX 76137 |
| Product Code | HBE |
| Subsequent Product Code | HBC |
| Subsequent Product Code | HRX |
| Subsequent Product Code | HWE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-26 |
| Decision Date | 2012-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169013155 | K121264 | 000 |
| 00643169013148 | K121264 | 000 |