Cleared Traditional

INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM

K022887 · Osteomed Corp. · Orthopedic
Nov 2002
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K022887 is an FDA 510(k) clearance for the INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM, a Prosthesis, Toe, Constrained, Polymer (Class II — Special Controls, product code KWH), submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on November 26, 2002, 88 days after receiving the submission on August 30, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3720.

Submission Details

510(k) Number K022887 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2002
Decision Date November 26, 2002
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWH — Prosthesis, Toe, Constrained, Polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3720