The following data is part of a premarket notification filed by Iconn Orthopedics, Llc with the FDA for Iconn Campbell Interference Screw.
| Device ID | K180670 |
| 510k Number | K180670 |
| Device Name: | ICONN Campbell Interference Screw |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-14 |
| Decision Date | 2018-12-07 |
| Summary: | summary |