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 | K180573 |
| 510k Number | K180573 |
| Device Name: | Responsive Arthroscopy Interference Screw System |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811714031026 | K180573 | 000 |
| 00811714033457 | K180573 | 000 |
| 00811714033402 | K180573 | 000 |
| 00811714033310 | K180573 | 000 |
| 00811714033266 | K180573 | 000 |
| 00811714033211 | K180573 | 000 |
| 00811714033150 | K180573 | 000 |
| 00811714033105 | K180573 | 000 |
| 00811714033051 | K180573 | 000 |
| 00811714032993 | K180573 | 000 |
| 00811714032948 | K180573 | 000 |
| 00811714032894 | K180573 | 000 |
| 00811714032832 | K180573 | 000 |
| 00811714032788 | K180573 | 000 |
| 00811714033525 | K180573 | 000 |
| 00811714033563 | K180573 | 000 |
| 00811714030814 | K180573 | 000 |
| 00811714030654 | K180573 | 000 |
| 00811714034164 | K180573 | 000 |
| 00811714034096 | K180573 | 000 |
| 00811714034041 | K180573 | 000 |
| 00811714034003 | K180573 | 000 |
| 00811714033938 | K180573 | 000 |
| 00811714033884 | K180573 | 000 |
| 00811714033846 | K180573 | 000 |
| 00811714033778 | K180573 | 000 |
| 00811714033723 | K180573 | 000 |
| 00811714033686 | K180573 | 000 |
| 00811714033617 | K180573 | 000 |
| 00811714032733 | K180573 | 000 |