Cleared Special

FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP

K140127 · Pontis Orthopaedics, LLC · General & Plastic Surgery

May 2014

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K140127 is an FDA 510(k) clearance for the FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP, a Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (Class II — Special Controls, product code GAQ), submitted by Pontis Orthopaedics, LLC (San Francisco, US). The FDA issued a Cleared decision on May 28, 2014, 132 days after receiving the submission on January 16, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4495.

Submission Details

510(k) Number	K140127 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 2014
Decision Date	May 28, 2014
Days to Decision	132 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GAQ — Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4495