The following data is part of a premarket notification filed by Hand Innovations, Inc. with the FDA for Shoulder Fixation System.
| Device ID | K042059 |
| 510k Number | K042059 |
| Device Name: | SHOULDER FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | HAND INNOVATIONS, INC. 8905 SW 87TH AVENUE SUITE 220 Miami, FL 33176 |
| Contact | Al Weisenborn |
| Correspondent | Al Weisenborn HAND INNOVATIONS, INC. 8905 SW 87TH AVENUE SUITE 220 Miami, FL 33176 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-30 |
| Decision Date | 2004-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868443886 | K042059 | 000 |
| 00887868073052 | K042059 | 000 |
| 00887868073045 | K042059 | 000 |
| 00887868072994 | K042059 | 000 |
| 00887868072987 | K042059 | 000 |