The following data is part of a premarket notification filed by Responsive Arthroscopy Llc with the FDA for Responsive Arthroscopy Suture Anchor System.
| Device ID | K202153 |
| 510k Number | K202153 |
| Device Name: | Responsive Arthroscopy Suture Anchor System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Responsive Arthroscopy LLC 701 N. 3rd Street, Suite 208 Minneapolis, MN 55401 |
| Contact | Douglas Korhs |
| Correspondent | Kristen Pena Cor Medical Ventures LLC 215 S. Highway 101 Suite 200 Solana Beach, CA 92075 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-03 |
| Decision Date | 2020-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811714035321 | K202153 | 000 |
| 00811714035314 | K202153 | 000 |