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 |