The following data is part of a premarket notification filed by Small Bone Innovations Inc. with the FDA for Sbi Sr Mtp Toe Implant.
| Device ID | K073635 |
| 510k Number | K073635 |
| Device Name: | SBI SR MTP TOE IMPLANT |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | SMALL BONE INNOVATIONS INC. 1331 H STREET NW, 12TH FL Washington, DC 20005 |
| Contact | Jeffrey Zigler |
| Correspondent | Jeffrey Zigler SMALL BONE INNOVATIONS INC. 1331 H STREET NW, 12TH FL Washington, DC 20005 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-03-19 |
| Summary: | summary |