Cleared Traditional

K251134 - RipCord (FDA 510(k) Clearance)

K251134 · TriMed, Inc. · Orthopedic device

Jul 2025

Decision

91d

Days

Class 2

Risk

K251134 is an FDA 510(k) clearance for the RipCord. This device is classified as a Washer, Bolt Nut (Class II - Special Controls, product code HTN).

Submitted by TriMed, Inc. (Santa Clarita, US). The FDA issued a Cleared decision on July 11, 2025, 91 days after receiving the submission on April 11, 2025.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K251134 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 11, 2025
Decision Date	July 11, 2025
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF