The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Vlp Mini-mod Small Bone Plating System 1.5mm Plates And Screws.
Device ID | K143050 |
510k Number | K143050 |
Device Name: | VLP Mini-Mod Small Bone Plating System 1.5mm Plates And Screws |
Classification | Plate, Fixation, Bone |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
Contact | Samantha Staubach |
Correspondent | Samantha Staubach SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-23 |
Decision Date | 2014-12-18 |
Summary: | summary |