Cleared Traditional

RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS

K051479 · Biomet Manufacturing, Inc. · Orthopedic
Aug 2005
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K051479 is an FDA 510(k) clearance for the RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS, a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 10, 2005, 68 days after receiving the submission on June 3, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number K051479 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2005
Decision Date August 10, 2005
Days to Decision 68 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3510

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