Cleared Traditional

LnK Posterior Cervical Fixation System

K143278 · L & K Biomed Co., Ltd. · Orthopedic
Jul 2015
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K143278 is an FDA 510(k) clearance for the LnK Posterior Cervical Fixation System, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by L & K Biomed Co., Ltd. (Giheung-Gu, Yongin-Si, KR). The FDA issued a Cleared decision on July 29, 2015, 257 days after receiving the submission on November 14, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K143278 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2014
Decision Date July 29, 2015
Days to Decision 257 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWP — Appliance, Fixation, Spinal Interlaminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3050

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