The following data is part of a premarket notification filed by Responsive Arthroscopy Llc with the FDA for Responsive Arthroscopy Thunderbolt System.
| Device ID | K203121 |
| 510k Number | K203121 |
| Device Name: | Responsive Arthroscopy Thunderbolt System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Responsive Arthroscopy LLC 701 N 3rd Street, Suite 208 Minneapolis, MN 55401 |
| Contact | Douglas Kohrs |
| Correspondent | Benjamin Arnold Cor Medical Ventures, Inc. 2010 Jimmy Durante Boulevard, Suite 200 Del Mar, CA 92014 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-16 |
| Decision Date | 2021-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811714035352 | K203121 | 000 |
| 00811714035345 | K203121 | 000 |