The following data is part of a premarket notification filed by Small Bone Innovations, Inc. with the FDA for Mini Rail External Fixator System.
| Device ID | K093550 |
| 510k Number | K093550 |
| Device Name: | MINI RAIL EXTERNAL FIXATOR SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SMALL BONE INNOVATIONS, INC. 1380 S. PENNSYLVANIA AVE. Morrisville, PA 19067 |
| Contact | John Minier |
| Correspondent | John Minier SMALL BONE INNOVATIONS, INC. 1380 S. PENNSYLVANIA AVE. Morrisville, PA 19067 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-17 |
| Decision Date | 2010-01-07 |
| Summary: | summary |