The following data is part of a premarket notification filed by Hand Innovations, Llc. with the FDA for Shoulder Nail Plate.
| Device ID | K052294 |
| 510k Number | K052294 |
| Device Name: | SHOULDER NAIL PLATE |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-23 |
| Decision Date | 2005-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304546417 | K052294 | 000 |
| 00887868072734 | K052294 | 000 |