The following data is part of a premarket notification filed by Hand Innovations, Llc. with the FDA for Fragment Plate System.
| Device ID | K061748 |
| 510k Number | K061748 |
| Device Name: | FRAGMENT PLATE SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | HAND INNOVATIONS, LLC. 700 ORTHOPAEDIC DRIVE PO BOX 988 Warsaw, IN 46581 |
| Contact | Natalie S Heck |
| Correspondent | Natalie S Heck HAND INNOVATIONS, LLC. 700 ORTHOPAEDIC DRIVE PO BOX 988 Warsaw, IN 46581 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-21 |
| Decision Date | 2006-07-17 |
| Summary: | summary |