Cleared Traditional

K230595 - OsteoCentric ACL Fixation System
(FDA 510(k) Clearance)

K230595 · OsteoCentric Technologies · Orthopedic

Jun 2023

Decision

118d

Days

Class 2

Risk

K230595 is an FDA 510(k) clearance for the OsteoCentric ACL Fixation System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by OsteoCentric Technologies (Logan, US). The FDA issued a Cleared decision on June 29, 2023, 118 days after receiving the submission on March 3, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K230595 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 2023
Decision Date	June 29, 2023
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF