The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Compression Ft Screws.
Device ID | K132217 |
510k Number | K132217 |
Device Name: | ARTHREX COMPRESSION FT SCREWS |
Classification | Screw, Fixation, Bone |
Applicant | ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples, FL 34108 -1945 |
Contact | Courtney Smith |
Correspondent | Courtney Smith ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples, FL 34108 -1945 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-17 |
Decision Date | 2013-11-25 |
Summary: | summary |