The following data is part of a premarket notification filed by Small Bone Innovations Inc. with the FDA for Sbi Twistofix.
| Device ID | K071541 |
| 510k Number | K071541 |
| Device Name: | SBI TWISTOFIX |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| 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 | 2007-09-10 |
| Summary: | summary |