The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Cabling System Trochanter Hook.
Device ID | K043252 |
510k Number | K043252 |
Device Name: | CABLING SYSTEM TROCHANTER HOOK |
Classification | Cerclage, Fixation |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | John Reabe |
Correspondent | John Reabe SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | JDQ |
CFR Regulation Number | 888.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-11-23 |
Decision Date | 2005-01-14 |
Summary: | summary |