The following data is part of a premarket notification filed by Responsive Arthroscopy Llc with the FDA for Responsive Arthroscopy Interference Screw System.
| Device ID | K202569 |
| 510k Number | K202569 |
| Device Name: | Responsive Arthroscopy Interference Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | Responsive Arthroscopy LLC 701 N. 3rd Street, Suite 208 Minneapolis, MN 55401 |
| Contact | Douglas Kohrs |
| Correspondent | Kristen Pena Cor Medical Ventures 215 S. Highway 101, Suite 200 Solana Beach, CA 92075 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-04 |
| Decision Date | 2020-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811714035178 | K202569 | 000 |
| 00811714035161 | K202569 | 000 |
| 00811714035130 | K202569 | 000 |
| 00811714035109 | K202569 | 000 |