The following data is part of a premarket notification filed by Safetyfix Medical Technologies, Inc. with the FDA for Safetyfix Easyout System.
| Device ID | K180753 |
| 510k Number | K180753 |
| Device Name: | SafetyFix EasyOut System |
| Classification | Screw, Fixation, Bone |
| Applicant | SafetyFix Medical Technologies, Inc. 8637 Delmar Blvd St. Louis, MO 63124 |
| Contact | Michael Horwitz |
| Correspondent | Ken Pilgrim Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-22 |
| Decision Date | 2018-04-20 |
| Summary: | summary |