The following data is part of a premarket notification filed by Kalitec Direct, Llc with the FDA for Kalitec Direct Inseption™ Mis Fixation System.
| Device ID | K163471 |
| 510k Number | K163471 |
| Device Name: | Kalitec Direct InSePtion™ MIS Fixation System |
| Classification | Spinous Process Plate |
| Applicant | KALITEC DIRECT, LLC 618 E. SOUTH STREET SUITE 500 Orlando, FL 32801 |
| Contact | Keith Cannan |
| Correspondent | Justin Eggleton MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS LLC 1050 K STREET NORTHWEST, SUITE 1000 Washington, DC 20001 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-12 |
| Decision Date | 2017-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07314ILP0010 | K163471 | 000 |