The following data is part of a premarket notification filed by Iconn Orthopedics, Llc with the FDA for Iconn Answer Ii Suture Anchor.
| Device ID | K181680 |
| 510k Number | K181680 |
| Device Name: | ICONN Answer II Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ICONN Orthopedics, LLC 400 Union Hill Drive, Suite 150 Birmingham, AL 35209 |
| Contact | Whitt Israel |
| Correspondent | Whitt Israel ICONN Orthopedics, LLC 400 Union Hill Drive, Suite 150 Birmingham, AL 35209 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-26 |
| Decision Date | 2018-08-09 |
| Summary: | summary |