The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew, Inc. Vlp Foot Plating, Screw System And Accessories.
Device ID | K090675 |
510k Number | K090675 |
Device Name: | SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES |
Classification | Plate, Fixation, Bone |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Jahanvi Agnihotri |
Correspondent | Jahanvi Agnihotri SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | HRS |
Subsequent Product Code | HTY |
Subsequent Product Code | HWC |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-03-13 |
Decision Date | 2009-06-04 |
Summary: | summary |