The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Wmt Implantable K-wire.
Device ID | K132895 |
510k Number | K132895 |
Device Name: | WMT IMPLANTABLE K-WIRE |
Classification | Pin, Fixation, Smooth |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Contact | Leslie Fitch |
Correspondent | Leslie Fitch WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-09-16 |
Decision Date | 2013-10-23 |
Summary: | summary |