The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Salvation 3di Plating System.
Device ID | K140792 |
510k Number | K140792 |
Device Name: | SALVATION 3DI PLATING SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
Contact | Leslie Fitch |
Correspondent | Leslie Fitch WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-31 |
Decision Date | 2014-05-22 |
Summary: | summary |