Cleared Traditional

BONE PLATE; BONE SCREW

K110926 · Biomaterials Korea, Inc. · Dental
Dec 2011
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K110926 is an FDA 510(k) clearance for the BONE PLATE; BONE SCREW, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Biomaterials Korea, Inc. (Greenwood Village, US). The FDA issued a Cleared decision on December 8, 2011, 251 days after receiving the submission on April 1, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K110926 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2011
Decision Date December 08, 2011
Days to Decision 251 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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