The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Xps Nexus System, Xps Nexus Foot Control, Xps Nexus Iv Pole.
| Device ID | K150728 |
| 510k Number | K150728 |
| Device Name: | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Gabriela Anchonda |
| Correspondent | Gabriela Anchondo MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-20 |
| Decision Date | 2015-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994933676 | K150728 | 000 |
| 00643169789609 | K150728 | 000 |
| 00643169434141 | K150728 | 000 |
| 00643169434134 | K150728 | 000 |
| 00763000007461 | K150728 | 000 |
| 00763000007454 | K150728 | 000 |
| 00763000172091 | K150728 | 000 |
| 00763000299217 | K150728 | 000 |