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

FDA 510(k)

RibFix Blu Thoracic Fixation System

K-Number: K212608 · 2022-04-22

ApplicantBiomet Microfixation
Decision Date2022-04-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RibFix Blu Thoracic Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K212608. 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 Blu Thoracic Fixation System?

RibFix Blu Thoracic Fixation System is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Biomet Microfixation. The 510(k) number is K212608.

When did RibFix Blu Thoracic Fixation System receive FDA 510(k) clearance?

RibFix Blu Thoracic Fixation System received FDA 510(k) clearance on 2022-04-22, under 510(k) number K212608.

Who is the listed applicant for RibFix Blu Thoracic Fixation System?

The FDA 510(k) record lists Biomet Microfixation as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for RibFix Blu Thoracic Fixation System is HRS.

Other records listing Biomet Microfixation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P020016Unknown DeviceK261002Pectus Blu SystemK241709Pectus Blu Support Bar SystemK2231992.1 x 255mm Drill, 22mm StopK212782SternaLock Sternal Closure SystemK213712Pectus Support Bar System

View all 14 devices →

Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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.

↑