The following data is part of a premarket notification filed by Small Bone Innovations, Llc with the FDA for Sbi K-wires.
| Device ID | K051605 |
| 510k Number | K051605 |
| Device Name: | SBI K-WIRES |
| Classification | Pin, Fixation, Smooth |
| Applicant | SMALL BONE INNOVATIONS, LLC 1711 S. PENNSYLVANIA AVENUE Morrisville, PA 19067 |
| Contact | Donald Guthner |
| Correspondent | Donald Guthner SMALL BONE INNOVATIONS, LLC 1711 S. PENNSYLVANIA AVENUE Morrisville, PA 19067 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-16 |
| Decision Date | 2005-08-10 |
| Summary: | summary |