FDA 510(k)

RibFix Titan Fixation System

K-Number: K241282 · 2024-08-19

Decision Date2024-08-19

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

RibFix Titan Fixation System is a medical device manufactured by Riverpoint Medical. It received FDA 510(k) clearance on 2024-08-19 under approval number K241282. 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 RibFix Titan Fixation System?

RibFix Titan Fixation System is a medical device that received FDA 510(k) clearance on 2024-08-19. It is manufactured by Riverpoint Medical. The 510(k) number is K241282.

When was RibFix Titan Fixation System approved by the FDA?

RibFix Titan Fixation System received FDA 510(k) clearance on 2024-08-19, under approval number K241282.

What company makes RibFix Titan Fixation System?

RibFix Titan Fixation System is manufactured by Riverpoint Medical.

What is the FDA product code for RibFix Titan Fixation System?

The FDA product code for RibFix Titan 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 NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT07079774 TrueLok Elevate PMCF Study RECRUITING

Other Devices by Riverpoint Medical

K160655OrthoButton CL K153307HS SutureTape K171060OrthoButton AL K190817HS Fiber K202399OrthoButton FL K203740JuggerKnot Soft Anchor

View all 19 devices →

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.