The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Sentio Mmg Pedicle Access Needles.
| Device ID | K173134 |
| 510k Number | K173134 |
| Device Name: | SENTIO MMG Pedicle Access Needles |
| Classification | Neurosurgical Nerve Locator |
| Applicant | Medos International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Sheree Geller |
| Correspondent | Sheree Geller DePuy Synthes Spine 325 Paramount Drive Raynham, MA 02767 |
| Product Code | PDQ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034534824 | K173134 | 000 |
| 10705034534817 | K173134 | 000 |