Cleared Traditional

K231944 - CATAMARAN SI Joint Fusion System (FDA 510(k) Clearance)

K231944 · Tenon Medical, Inc. · Orthopedic device

Aug 2023

Decision

55d

Days

Class 2

Risk

K231944 is an FDA 510(k) clearance for the CATAMARAN SI Joint Fusion System. This device is classified as a Sacroiliac Joint Fixation (Class II - Special Controls, product code OUR).

Submitted by Tenon Medical, Inc. (Los Gatos, US). The FDA issued a Cleared decision on August 24, 2023, 55 days after receiving the submission on June 30, 2023.

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

Submission Details

510(k) Number	K231944 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 30, 2023
Decision Date	August 24, 2023
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF