The following data is part of a premarket notification filed by Truemed Group Llc with the FDA for Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt.
| Device ID | K172189 |
| 510k Number | K172189 |
| Device Name: | Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Truemed Group LLC 2002 Timberloch Place Suite 200 The Woodlands, TX 77380 |
| Contact | Nina Galeana Rodriguez |
| Correspondent | Nina Galeana Rodriguez Truemed Group LLC 2002 Timberloch Place Suite 200 The Woodlands, TX 77380 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-20 |
| Decision Date | 2018-01-16 |
| Summary: | summary |