Cleared Traditional

K133579 - MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS
(FDA 510(k) Clearance)

K133579 · Pontis Orthopaedics, LLC · Orthopedic
Jun 2014
Decision
217d
Days
Class 2
Risk

K133579 is an FDA 510(k) clearance for the MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Pontis Orthopaedics, LLC (San Francisco, US). The FDA issued a Cleared decision on June 26, 2014, 217 days after receiving the submission on November 21, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K133579 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2013
Decision Date June 26, 2014
Days to Decision 217 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040