The following data is part of a premarket notification filed by Izi Medical Products Llc with the FDA for Navigated Pedicle Access Kit.
| Device ID | K191012 |
| 510k Number | K191012 |
| Device Name: | Navigated Pedicle Access Kit |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | IZI Medical Products LLC 5 Easter Court, Suite J Owings Mills, MD 21117 |
| Contact | Qiang Cao |
| Correspondent | Daniel Ziskind 7D Surgical Inc. 60 Scarsdale Road, Unit 118 Toronto, CA M3b 2r7 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-16 |
| Decision Date | 2019-08-07 |