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 | K180951 |
| 510k Number | K180951 |
| Device Name: | Responsive Arthroscopy Suture Anchor System |
| 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 | 2018-04-11 |
| Decision Date | 2019-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811714030098 | K180951 | 000 |
| 00811714034355 | K180951 | 000 |
| 00811714034379 | K180951 | 000 |
| 00811714034386 | K180951 | 000 |
| 00811714034393 | K180951 | 000 |
| 00811714034409 | K180951 | 000 |
| 00811714034416 | K180951 | 000 |
| 00811714035413 | K180951 | 000 |
| 00811714035420 | K180951 | 000 |
| 00811714030012 | K180951 | 000 |
| 00811714030029 | K180951 | 000 |
| 00811714032467 | K180951 | 000 |
| 00811714030050 | K180951 | 000 |
| 00811714030067 | K180951 | 000 |
| 00811714030081 | K180951 | 000 |
| 00811714034331 | K180951 | 000 |