The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Peri-loc Periarticular Locked Plating System Hexalobular Bone Screws.
Device ID | K082516 |
510k Number | K082516 |
Device Name: | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS |
Classification | Screw, Fixation, Bone |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Laura Sejnowski |
Correspondent | Laura Sejnowski SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-09-02 |
Decision Date | 2008-09-17 |
Summary: | summary |