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FDA 510(k)

Biomet Microfixation RibFix Blu Thoracic Fixation System

K-Number: K152253 · 2016-03-24

ApplicantBiomet Microfixation
Decision Date2016-03-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Biomet Microfixation RibFix Blu Thoracic Fixation System is a medical device manufactured by Biomet Microfixation. It received FDA 510(k) clearance on 2016-03-24 under approval number K152253. 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 Biomet Microfixation RibFix Blu Thoracic Fixation System?

Biomet Microfixation RibFix Blu Thoracic Fixation System is a medical device that received FDA 510(k) clearance on 2016-03-24. It is manufactured by Biomet Microfixation. The 510(k) number is K152253.

When was Biomet Microfixation RibFix Blu Thoracic Fixation System approved by the FDA?

Biomet Microfixation RibFix Blu Thoracic Fixation System received FDA 510(k) clearance on 2016-03-24, under approval number K152253.

What company makes Biomet Microfixation RibFix Blu Thoracic Fixation System?

Biomet Microfixation RibFix Blu Thoracic Fixation System is manufactured by Biomet Microfixation.

What is the FDA product code for Biomet Microfixation RibFix Blu Thoracic Fixation System?

The FDA product code for Biomet Microfixation RibFix Blu Thoracic 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 NCT05639569 Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study ACTIVE_NOT_RECRUITING NCT02161874 Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06658730 Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance RECRUITING

Other Devices by Biomet Microfixation

K162974Biomet Microfixation RibFix Blu Thoracic Fixation System K163007Biomet Microfixation SternaLock 360 Sternal Closure System K161896Biomet Microfixation Sternal Closure System K190576WalterLorenz Surgical Assist Arm Scope Holder K213208Twist Drills K202969Biomet Microfixation OmniMax MMF System

View all 12 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.

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