Cleared Traditional

Instruments for LINK MEGASYSTEM-C Family

K190181 · LinkBio Corp. · Orthopedic
Oct 2019
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K190181 is an FDA 510(k) clearance for the Instruments for LINK MEGASYSTEM-C Family, a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by LinkBio Corp. (Rockaway, US). The FDA issued a Cleared decision on October 25, 2019, 266 days after receiving the submission on February 1, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number K190181 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2019
Decision Date October 25, 2019
Days to Decision 266 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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