The following data is part of a premarket notification filed by Intelligent Implant Systems, Llc with the FDA for Mediant Anterior Cervical Plating System.
| Device ID | K173935 |
| 510k Number | K173935 |
| Device Name: | Mediant Anterior Cervical Plating System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Intelligent Implant Systems, LLC 3300 International Airport Dr; STE 1100 Charlotte, NC 28208 |
| Contact | Michael Nutt |
| Correspondent | Michael Nutt Intelligent Implant Systems, LLC 3300 International Airport Dr; STE 1100 Charlotte, NC 28208 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-26 |
| Decision Date | 2018-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814033021259 | K173935 | 000 |
| 00814033021044 | K173935 | 000 |
| 00814033021037 | K173935 | 000 |
| 00814033021020 | K173935 | 000 |
| 00814033021013 | K173935 | 000 |
| 00814033021006 | K173935 | 000 |
| 00814033020993 | K173935 | 000 |
| 00814033020986 | K173935 | 000 |
| 00814033020979 | K173935 | 000 |
| 00814033020962 | K173935 | 000 |
| 00814033020955 | K173935 | 000 |
| 00814033020948 | K173935 | 000 |
| 00814033020931 | K173935 | 000 |
| 00814033020924 | K173935 | 000 |
| 00814033020917 | K173935 | 000 |
| 00814033020900 | K173935 | 000 |
| 00814033021280 | K173935 | 000 |
| 00814033021273 | K173935 | 000 |
| 00814033021051 | K173935 | 000 |
| 00814033021068 | K173935 | 000 |
| 00814033021075 | K173935 | 000 |
| 00814033021242 | K173935 | 000 |
| 00814033021235 | K173935 | 000 |
| 00814033021228 | K173935 | 000 |
| 00814033021211 | K173935 | 000 |
| 00814033021204 | K173935 | 000 |
| 00814033021198 | K173935 | 000 |
| 00814033021181 | K173935 | 000 |
| 00814033021174 | K173935 | 000 |
| 00814033021167 | K173935 | 000 |
| 00814033021150 | K173935 | 000 |
| 00814033021143 | K173935 | 000 |
| 00814033021136 | K173935 | 000 |
| 00814033021129 | K173935 | 000 |
| 00814033021112 | K173935 | 000 |
| 00814033021105 | K173935 | 000 |
| 00814033021099 | K173935 | 000 |
| 00814033021082 | K173935 | 000 |
| 00814033021266 | K173935 | 000 |