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FDA 510(k)

Pectus Blu Support Bar System

K-Number: K212841 · 2022-01-07

ApplicantBiomet Micofixation
Decision Date2022-01-07
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pectus Blu Support Bar System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Micofixation. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K212841. 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 Pectus Blu Support Bar System?

Pectus Blu Support Bar System is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Biomet Micofixation. The 510(k) number is K212841.

When did Pectus Blu Support Bar System receive FDA 510(k) clearance?

Pectus Blu Support Bar System received FDA 510(k) clearance on 2022-01-07, under 510(k) number K212841.

Who is the listed applicant for Pectus Blu Support Bar System?

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

What is the FDA product code for Pectus Blu Support Bar System?

The FDA product code for Pectus Blu Support Bar System is HRS.

Other records listing Biomet Micofixation 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.

K2130722.1 x 255mm Drill, 22mm StopK203474Biomet Microfixation RibFix Advantage System

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.

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Official Source

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

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