The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Hv Screw System.
Device ID | K170889 |
510k Number | K170889 |
Device Name: | HV Screw System |
Classification | Screw, Fixation, Bone |
Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
Contact | Tara Conrad |
Correspondent | Tara Conrad Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-24 |
Decision Date | 2017-04-26 |
Summary: | summary |