The following data is part of a premarket notification filed by Austin Miller Trauma Llc with the FDA for Austin Miller Large External Fixation System.
| Device ID | K181528 |
| 510k Number | K181528 |
| Device Name: | Austin Miller Large External Fixation System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Austin Miller Trauma LLC 3011 Centre Oak Way Suite 102 Germantown, TN 38138 |
| Contact | Steve Miller |
| Correspondent | Steve Miller Austin Miller Trauma LLC 3011 Centre Oak Way Suite 102 Germantown, TN 38138 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-11 |
| Decision Date | 2019-02-28 |
| Summary: | summary |