Cleared Traditional

RipCord

K251134 · TriMed, Inc. · Orthopedic
Jul 2025
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K251134 is an FDA 510(k) clearance for the RipCord, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by TriMed, Inc. (Valencia, 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 review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K251134 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HTN — Washer, Bolt Nut
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

More from TriMed, Inc.

View all
TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)
K254002 · HRS · Jan 2026
Distal Xtremities System
K252061 · HRS · Aug 2025
TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
K251945 · HRS · Jul 2025
TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)
K250929 · HRS · Jun 2025
TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)
K250935 · HRS · May 2025