The following data is part of a premarket notification filed by Dunamis Llc with the FDA for Dunamis Punchtac Suture Anchors.
| Device ID | K193245 |
| 510k Number | K193245 |
| Device Name: | Dunamis PunchTac Suture Anchors |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-25 |
| Decision Date | 2020-02-14 |