Submission Details
| 510(k) Number | K201497 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 05, 2020 |
| Decision Date | October 28, 2020 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
EVOS Cabling System
Oct 2020
Decision
145d
Days
Class 2
Risk
About This 510(k) Submission
K201497 is an FDA 510(k) clearance for the EVOS Cabling System, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on October 28, 2020, 145 days after receiving the submission on June 5, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.
Device Classification
| Product Code | JDQ — Cerclage, Fixation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3010 |
Manufacturer
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Marquette, MI · US
Sarah Pleaugh
15 submissions
15 cleared
Similar Devices — JDQ Cerclage, Fixation
All 128
K243905 · GM Dos Reis Industria e Comercio Ltda.
· Aug 2025
K243344 · Arthrex, Inc.
· Feb 2025
K232733 · Medacta International S.A.
· May 2024
K233949 · Smith & Nephew, Inc.
· Mar 2024
K232986 · Circumfix Solutions, Inc.
· Jan 2024
K230976 · Arthrex, Inc.
· Aug 2023
More from Pioneer Surgical...
View all
K200095
· OLO · Jun 2020
K193468
· JDQ · Mar 2020
K192800
· NKB · Jan 2020
K192718
· MAX · Dec 2019
K190498
· MAX · Jul 2019