The following data is part of a premarket notification filed by Surgtech Inc with the FDA for Surgtech Trauma System.
| Device ID | K161894 |
| 510k Number | K161894 |
| Device Name: | SurgTech Trauma System |
| Classification | Screw, Fixation, Bone |
| Applicant | SURGTECH INC 24600 CENTER RIDGE ROAD, SUITE 195, Westlake, OH 44145 |
| Contact | Xuegong Yu |
| Correspondent | Karen E. Warden BACKROADS CONSULTING INC. PO BOX 566 Chesterland, OH 44026 -0566 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-11 |
| Decision Date | 2017-02-21 |
| Summary: | summary |