The following data is part of a premarket notification filed by Surgtech, Inc., with the FDA for Surgtech Bipolar Head System.
Device ID | K173455 |
510k Number | K173455 |
Device Name: | SurgTech Bipolar Head System |
Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
Applicant | SurgTech, Inc., 24600 Center Ridge Road, Suite 195 Westlake, OH 44145 |
Contact | Xuegong Yu |
Correspondent | Kellen Hills Orchid Design 4600 E Shelby Dr Memphis, TN 38118 |
Product Code | KWY |
CFR Regulation Number | 888.3390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-07 |
Decision Date | 2018-06-14 |
Summary: | summary |