The following data is part of a premarket notification filed by Responsive Arthroscopy Llc with the FDA for Responsive Arthroscopy Mustang And Mustang Knotless Suture Anchors.
Device ID | K222763 |
510k Number | K222763 |
Device Name: | Responsive Arthroscopy Mustang And Mustang Knotless Suture Anchors |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | Responsive Arthroscopy LLC 701 N. 3rd Street, Suite 208 Minneapolis, MN 55401 |
Contact | Garrett Ahlborg |
Correspondent | Garrett Ahlborg Responsive Arthroscopy LLC 701 N. 3rd Street, Suite 208 Minneapolis, MN 55401 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-09-13 |
Decision Date | 2022-10-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00811714035604 | K222763 | 000 |
00811714035598 | K222763 | 000 |
00811714035581 | K222763 | 000 |
00811714035574 | K222763 | 000 |
00811714035567 | K222763 | 000 |
00811714035543 | K222763 | 000 |