The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Wright Jones Fracture System.
Device ID | K183026 |
510k Number | K183026 |
Device Name: | Wright Jones Fracture System |
Classification | Screw, Fixation, Bone |
Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
Contact | Antonio Ayala |
Correspondent | Antonio Ayala 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 | 2018-11-01 |
Decision Date | 2019-03-13 |
Summary: | summary |