The following data is part of a premarket notification filed by Tigon Medical with the FDA for Tigon Medical Button System.
| Device ID | K211049 |
| 510k Number | K211049 |
| Device Name: | Tigon Medical Button System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Tigon Medical 838 Ritchie HWY, Suite 5 Severna Park, MD 21146 |
| Contact | Jeremy Clark |
| Correspondent | Jeremy Clark Tigon Medical 838 Ritchie HWY, Suite 5 Severna Park, MD 21146 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-08 |
| Decision Date | 2021-08-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854288008735 | K211049 | 000 |