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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 a medical device manufactured by Biomet Micofixation. It received FDA 510(k) clearance on 2022-01-07 under approval 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. It is manufactured by Biomet Micofixation. The 510(k) number is K212841.

When was Pectus Blu Support Bar System approved by the FDA?

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

What company makes Pectus Blu Support Bar System?

Pectus Blu Support Bar System is manufactured by Biomet Micofixation.

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

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

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 40775863 Use of the Learning Health System to Redesign and Implement a Clinical Decision Support System for Antimicrobial Stewardship. Studies in health technology and informatics (2025)

Other Devices by Biomet Micofixation

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Related Devices (Code: HRS)

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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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