Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SyndesMetrics Syndesmosis Repair System

K-Number: K172620 · 2017-11-08

ApplicantMortise Medical, LLC
Decision Date2017-11-08
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SyndesMetrics Syndesmosis Repair System is a medical device manufactured by Mortise Medical, LLC. It received FDA 510(k) clearance on 2017-11-08 under approval number K172620. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SyndesMetrics Syndesmosis Repair System?

SyndesMetrics Syndesmosis Repair System is a medical device that received FDA 510(k) clearance on 2017-11-08. It is manufactured by Mortise Medical, LLC. The 510(k) number is K172620.

When was SyndesMetrics Syndesmosis Repair System approved by the FDA?

SyndesMetrics Syndesmosis Repair System received FDA 510(k) clearance on 2017-11-08, under approval number K172620.

What company makes SyndesMetrics Syndesmosis Repair System?

SyndesMetrics Syndesmosis Repair System is manufactured by Mortise Medical, LLC.

What is the FDA product code for SyndesMetrics Syndesmosis Repair System?

The FDA product code for SyndesMetrics Syndesmosis Repair System is HTN.

Related Clinical Trials

NCT04097145 Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT04503395 ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES RECRUITING NCT03298477 EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study COMPLETED NCT06658730 Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance RECRUITING NCT03382457 Clinical Study of Edwards Cardioband FIT Valve Repair System ACTIVE_NOT_RECRUITING

Other Devices by Mortise Medical, LLC

K171964LigaMetrics Suture Anchors

Related Devices (Code: HTN)

K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc. K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc. K170440KISSloc Suture SystemArthrosurface, Inc. K162805Akros Fibulink Syndesmosis Repair KitAkros Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑