The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Peri-loc Periartricular Lck Pit Sys-prox Fem Plates/screws.calbe Access.
Device ID | K072818 |
510k Number | K072818 |
Device Name: | PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS |
Classification | Plate, Fixation, Bone |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | David Henley |
Correspondent | David Henley SMITH & NEPHEW, INC. 1450 BROOKS RD. 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 | 2007-10-02 |
Decision Date | 2007-11-19 |
Summary: | summary |