The following data is part of a premarket notification filed by Truemed Group, Llc with the FDA for Arzzt 3.5 / 4.5 Small & Large Fragments System.
| Device ID | K162507 |
| 510k Number | K162507 |
| Device Name: | Arzzt 3.5 / 4.5 Small & Large Fragments System |
| Classification | Plate, Fixation, Bone |
| Applicant | TRUEMED GROUP, LLC 20507 NANNETTE LN Sprint, TX 77388 |
| Contact | Jorge Castillo |
| Correspondent | Lara Luzak Registrar Corp 144 Research Drive Hampton, VA 23666 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-08 |
| Decision Date | 2017-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B61503134101 | K162507 | 000 |
| B61502095406 | K162507 | 000 |
| B61502095401 | K162507 | 000 |