Cleared Traditional

RHEAD RADIAL HEAD EXTENDED STEMS

K102180 · Small Bone Innovations, Inc. · Orthopedic
Dec 2010
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K102180 is an FDA 510(k) clearance for the RHEAD RADIAL HEAD EXTENDED STEMS, a Prosthesis, Elbow, Semi-constrained, Cemented (Class II — Special Controls, product code JDB), submitted by Small Bone Innovations, Inc. (Morrisville, US). The FDA issued a Cleared decision on December 20, 2010, 140 days after receiving the submission on August 2, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3160.

Submission Details

510(k) Number K102180 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2010
Decision Date December 20, 2010
Days to Decision 140 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDB — Prosthesis, Elbow, Semi-constrained, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3160