The following data is part of a premarket notification filed by Small Bone Innovations, Inc. with the FDA for Sbi Lateral Radio Capitellum.
| Device ID | K070236 |
| 510k Number | K070236 |
| Device Name: | SBI LATERAL RADIO CAPITELLUM |
| Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
| Applicant | SMALL BONE INNOVATIONS, INC. 505 PARK AVENUE, 14TH FLOOR Newyork, NY |
| Contact | Robert Hoehn |
| Correspondent | Robert Hoehn SMALL BONE INNOVATIONS, INC. 505 PARK AVENUE, 14TH FLOOR Newyork, NY |
| Product Code | JDB |
| CFR Regulation Number | 888.3160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-25 |
| Decision Date | 2007-02-21 |
| Summary: | summary |