Cleared Traditional

Sterile bone screw (PEEK ACL screw)

K202883 · Osteonic Co., Ltd. · Orthopedic

Nov 2020

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K202883 is an FDA 510(k) clearance for the Sterile bone screw (PEEK ACL screw), a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Osteonic Co., Ltd. (Guro-Gu, KR). The FDA issued a Cleared decision on November 25, 2020, 58 days after receiving the submission on September 28, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K202883 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2020
Decision Date	November 25, 2020
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF