The following data is part of a premarket notification filed by Small Bone Innovations, Llc with the FDA for Sbi Wristfit.
| Device ID | K051747 |
| 510k Number | K051747 |
| Device Name: | SBI WRISTFIT |
| Classification | Plate, Fixation, Bone |
| Applicant | SMALL BONE INNOVATIONS, LLC 505 PARK AVE., 14TH FLOOR New York, NY 10022 |
| Contact | Donald Guthner |
| Correspondent | Donald Guthner SMALL BONE INNOVATIONS, LLC 505 PARK AVE., 14TH FLOOR New York, NY 10022 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-29 |
| Decision Date | 2005-09-06 |
| Summary: | summary |