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 |