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 |