The following data is part of a premarket notification filed by Small Bone Innovations Inc. with the FDA for Sbi Trihedron Mtp Hemi Gt.
| Device ID | K062040 |
| 510k Number | K062040 |
| Device Name: | SBI TRIHEDRON MTP HEMI GT |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| 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 | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-19 |
| Decision Date | 2006-10-03 |
| Summary: | summary |