The following data is part of a premarket notification filed by Metric Medical Devices, Inc. with the FDA for Ifs Fixation Scaffold System.
Device ID | K152627 |
510k Number | K152627 |
Device Name: | IFS Fixation Scaffold System |
Classification | Pin, Fixation, Smooth |
Applicant | METRIC MEDICAL DEVICES, INC. 846 SILVER SPRINGS Helotes, TX 78023 |
Contact | W.casey Fox |
Correspondent | W.casey Fox METRIC MEDICAL DEVICES, INC. 846 SILVER SPRINGS Helotes, TX 78023 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-15 |
Decision Date | 2016-01-13 |
Summary: | summary |