The following data is part of a premarket notification filed by Responsive Arthroscopy Llc with the FDA for Responsive Arthroscopy Wedge Push-in Suture Anchors.
| Device ID | K181076 |
| 510k Number | K181076 |
| Device Name: | Responsive Arthroscopy Wedge Push-In Suture Anchors |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Responsive Arthroscopy LLC 701 N. 3rd Street, Suite 202 Minneapolis, MN 55401 |
| Contact | Doug Kohrs |
| Correspondent | Benjamin Arnold 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-24 |
| Decision Date | 2019-01-18 |
| Summary: | summary |