The following data is part of a premarket notification filed by Dunamis Llc with the FDA for Dunamis Fixation Button System.
| Device ID | K191319 |
| 510k Number | K191319 |
| Device Name: | Dunamis Fixation Button System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Dunamis LLC 509 E. Commerce Street Suite 3 Greenville, AL 36037 |
| Contact | Prithviraj Chavan |
| Correspondent | Hollace Rhodes MCRA, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-15 |
| Decision Date | 2019-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854629006697 | K191319 | 000 |
| 00854629006994 | K191319 | 000 |
| 40854629006916 | K191319 | 000 |
| 30854629006919 | K191319 | 000 |
| 20854629006912 | K191319 | 000 |
| 00850052601195 | K191319 | 000 |
| 00850052601225 | K191319 | 000 |
| 00850052601157 | K191319 | 000 |
| 00850052601096 | K191319 | 000 |
| 00850052601089 | K191319 | 000 |
| 10854629006809 | K191319 | 000 |
| 10854629006885 | K191319 | 000 |
| 00854629006970 | K191319 | 000 |
| 00854629006765 | K191319 | 000 |
| 00854629006758 | K191319 | 000 |
| 00854629006734 | K191319 | 000 |
| 00854629006963 | K191319 | 000 |
| 00854629006949 | K191319 | 000 |
| 00854629006925 | K191319 | 000 |
| 10854629006915 | K191319 | 000 |
| 10854629006908 | K191319 | 000 |
| 10854629006892 | K191319 | 000 |
| 00850052601072 | K191319 | 000 |