The following data is part of a premarket notification filed by Hand Innovations, Llc. with the FDA for Shoulder Fixation System.
| Device ID | K060290 |
| 510k Number | K060290 |
| Device Name: | SHOULDER FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | HAND INNOVATIONS, LLC. 8905 SW 87TH AVENUE SUITE 220 Miami, FL 33176 |
| Contact | Ernesto Hernandez |
| Correspondent | Ernesto Hernandez HAND INNOVATIONS, LLC. 8905 SW 87TH AVENUE SUITE 220 Miami, FL 33176 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-06 |
| Decision Date | 2006-02-27 |
| Summary: | summary |