The following data is part of a premarket notification filed by Medtronic Powered Surgical Solutions with the FDA for Medtronic Legend Pneumatic; Mr7 Pneumatic; Triton Pneumatic Drill System Incorporating Various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; And System Accessories.
| Device ID | K163182 |
| 510k Number | K163182 |
| Device Name: | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System Incorporating Various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; And System Accessories |
| Classification | Motor, Drill, Pneumatic |
| Applicant | Medtronic Powered Surgical Solutions 4620 North Beach Street Fox Worth, TX 76177 |
| Contact | Deep Pal |
| Correspondent | Deep Pal Medtronic Powered Surgical Solutions 4620 North Beach Street Fox Worth, TX 76177 |
| Product Code | HBB |
| Subsequent Product Code | DWH |
| Subsequent Product Code | EQJ |
| Subsequent Product Code | ERL |
| Subsequent Product Code | GET |
| Subsequent Product Code | HBE |
| Subsequent Product Code | HSZ |
| Subsequent Product Code | KFK |
| CFR Regulation Number | 882.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-14 |
| Decision Date | 2017-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000096762 | K163182 | 000 |
| 00763000430962 | K163182 | 000 |
| 00763000430979 | K163182 | 000 |
| 00763000337551 | K163182 | 000 |
| 00763000337568 | K163182 | 000 |
| 00763000337506 | K163182 | 000 |
| 00763000080143 | K163182 | 000 |
| 00763000080044 | K163182 | 000 |
| 00763000080068 | K163182 | 000 |
| 00763000080075 | K163182 | 000 |
| 00763000096717 | K163182 | 000 |
| 00763000096724 | K163182 | 000 |
| 00763000096748 | K163182 | 000 |
| 00763000096755 | K163182 | 000 |
| 00763000430955 | K163182 | 000 |