The following data is part of a premarket notification filed by Small Bone Innovations Inc. with the FDA for Sbi Foot And Ankle Cannulated Screw System, Model 100-0061.
| Device ID | K092754 |
| 510k Number | K092754 |
| Device Name: | SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 |
| Classification | Screw, Fixation, Bone |
| Applicant | SMALL BONE INNOVATIONS INC. 1380 SOUTH PENNSYLVANIA AVENUE Morrisville, PA 19067 |
| Contact | John Minier |
| Correspondent | John Minier SMALL BONE INNOVATIONS INC. 1380 SOUTH PENNSYLVANIA AVENUE Morrisville, PA 19067 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-09 |
| Decision Date | 2010-01-19 |
| Summary: | summary |