The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Trimit Screw, Model Ar-4161b.
Device ID | K031945 |
510k Number | K031945 |
Device Name: | ARTHREX TRIMIT SCREW, MODEL AR-4161B |
Classification | Screw, Fixation, Bone |
Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
Contact | Ann Waterhouse |
Correspondent | Ann Waterhouse ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-24 |
Decision Date | 2003-09-22 |
Summary: | summary |