The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Bone Plate System (bone Plates, Bone Screws And Accessories).
Device ID | K993106 |
510k Number | K993106 |
Device Name: | SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES) |
Classification | Plate, Fixation, Bone |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Janet Jojnson Green |
Correspondent | Janet Jojnson Green SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-09-17 |
Decision Date | 1999-12-09 |
Summary: | summary |