Cleared Traditional

Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)

K210122 · Osteonic Co., Ltd. · Orthopedic

Aug 2021

Decision

220d

Days

Class 2

Risk

About This 510(k) Submission

K210122 is an FDA 510(k) clearance for the Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw), a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Osteonic Co., Ltd. (Guro-Gu, KR). The FDA issued a Cleared decision on August 27, 2021, 220 days after receiving the submission on January 19, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K210122 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 19, 2021
Decision Date	August 27, 2021
Days to Decision	220 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF