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510(k) K143278

LnK Posterior Cervical Fixation System by L & K Biomed Co., Ltd. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2015
Date Received
November 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

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