TriMed Humeral Supracondylar Fixation System
K-Number: K151735 · 2016-01-29
ApplicantTriMed, Inc.
Decision Date2016-01-29
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TriMed Humeral Supracondylar Fixation System is a medical device manufactured by TriMed, Inc.. It received FDA 510(k) clearance on 2016-01-29 under approval number K151735. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TriMed Humeral Supracondylar Fixation System?
TriMed Humeral Supracondylar Fixation System is a medical device that received FDA 510(k) clearance on 2016-01-29. It is manufactured by TriMed, Inc.. The 510(k) number is K151735.
When was TriMed Humeral Supracondylar Fixation System approved by the FDA?
TriMed Humeral Supracondylar Fixation System received FDA 510(k) clearance on 2016-01-29, under approval number K151735.
What company makes TriMed Humeral Supracondylar Fixation System?
TriMed Humeral Supracondylar Fixation System is manufactured by TriMed, Inc..
What is the FDA product code for TriMed Humeral Supracondylar Fixation System?
The FDA product code for TriMed Humeral Supracondylar Fixation System is HRS.
Related Clinical Trials
NCT07222787
Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes
RECRUITING
NCT07277946
AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE
RECRUITING
NCT05019664
Affixus Natural Nail System Humeral Nail PMCF
ACTIVE_NOT_RECRUITING
NCT05762055
Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
ENROLLING_BY_INVITATION
NCT04389749
Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures
RECRUITING
NCT07245719
Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up
COMPLETED
Other Devices by TriMed, Inc.
Related Devices (Code: HRS)
K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.
K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.
K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation
K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation
K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG
K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG
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.