The following data is part of a premarket notification filed by Jointvue Llc with the FDA for Jfit Surgical Planner.
| Device ID | K173329 |
| 510k Number | K173329 |
| Device Name: | JFit Surgical Planner |
| Classification | System, Image Processing, Radiological |
| Applicant | JointVue LLC 2099 Thunderhead Rd., Suite 104 Knoxville, TN 37922 |
| Contact | Mohamed R. Mahfouz |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-10-23 |
| Decision Date | 2017-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850014885021 | K173329 | 000 |