The following data is part of a premarket notification filed by Small Bone Innovations, Inc. with the FDA for Anatomic Ankle Arthrodesis Interlocking Nail (a3 Interlocking Nail).
| Device ID | K130147 |
| 510k Number | K130147 |
| Device Name: | ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL) |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| 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 | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-22 |
| Decision Date | 2013-05-03 |
| Summary: | summary |