Cleared Traditional

K220901 - S-Core Implant System (FDA 510(k) Clearance)

K220901 · Subchondral Solutions, Inc. · Orthopedic device

Jul 2022

Decision

123d

Days

Class 2

Risk

K220901 is an FDA 510(k) clearance for the S-Core Implant System. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).

Submitted by Subchondral Solutions, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on July 29, 2022, 123 days after receiving the submission on March 28, 2022.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K220901 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 28, 2022
Decision Date	July 29, 2022
Days to Decision	123 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF