The following data is part of a premarket notification filed by Arrowhead Medical Device Technologies Llc with the FDA for Arrow-lok Digital System.
Device ID | K112675 |
510k Number | K112675 |
Device Name: | ARROW-LOK DIGITAL SYSTEM |
Classification | Pin, Fixation, Smooth |
Applicant | ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC 328 POPLAR VIEW LANE EAST SUITE 2 Collierville, TN 38017 |
Contact | Thomas J Twardzik |
Correspondent | Thomas J Twardzik ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC 328 POPLAR VIEW LANE EAST SUITE 2 Collierville, TN 38017 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-14 |
Decision Date | 2011-12-12 |
Summary: | summary |