The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Locking Bone Plate System (locking Bone Plates And Screws).
Device ID | K033669 |
510k Number | K033669 |
Device Name: | SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS) |
Classification | Plate, Fixation, Bone |
Applicant | SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
Contact | David Henley |
Correspondent | David Henley SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-11-21 |
Decision Date | 2003-12-10 |
Summary: | summary |