The following data is part of a premarket notification filed by Small Bone Innovations, Inc. with the FDA for Rhead Radial Head Extended Stems.
| Device ID | K102180 |
| 510k Number | K102180 |
| Device Name: | RHEAD RADIAL HEAD EXTENDED STEMS |
| Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
| Applicant | SMALL BONE INNOVATIONS, INC. 1380 S. PENNSYLVANIA AVE. Morrisville, PA 19067 |
| Contact | James O'connor |
| Correspondent | James O'connor SMALL BONE INNOVATIONS, INC. 1380 S. PENNSYLVANIA AVE. Morrisville, PA 19067 |
| Product Code | JDB |
| CFR Regulation Number | 888.3160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-02 |
| Decision Date | 2010-12-20 |
| Summary: | summary |