The following data is part of a premarket notification filed by Truemed Group, Llc with the FDA for Ins Hilden Tibial Arzzt.
| Device ID | K133166 |
| 510k Number | K133166 |
| Device Name: | INS HILDEN TIBIAL ARZZT |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | TRUEMED GROUP, LLC 144 RESEARCH DR. Hampton, VA 23669 |
| Contact | Rhonda Alexander |
| Correspondent | Rhonda Alexander TRUEMED GROUP, LLC 144 RESEARCH DR. Hampton, VA 23669 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-11-06 |
| Summary: | summary |