The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Ankle Fusion Plating System.
Device ID | K141735 |
510k Number | K141735 |
Device Name: | ARTHREX ANKLE FUSION PLATING SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
Contact | Laura Medlin |
Correspondent | Laura Medlin ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
Product Code | HRS |
Subsequent Product Code | HTN |
Subsequent Product Code | HWC |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-27 |
Decision Date | 2014-08-15 |
Summary: | summary |