The following data is part of a premarket notification filed by Small Bone Innovations Inc. with the FDA for Sbi Titanium Threaded Pin.
| Device ID | K071540 |
| 510k Number | K071540 |
| Device Name: | SBI TITANIUM THREADED PIN |
| Classification | Pin, Fixation, Threaded |
| Applicant | SMALL BONE INNOVATIONS INC. 505 PARK AVE., 14TH FLOOR New York, NY 10022 |
| Contact | Robert Hoehn |
| Correspondent | Robert Hoehn SMALL BONE INNOVATIONS INC. 505 PARK AVE., 14TH FLOOR New York, NY 10022 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-05 |
| Decision Date | 2007-08-08 |
| Summary: | summary |