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FDA 510(k)

Biomet Microfixation SternaLock 360 Sternal Closure System

K-Number: K163007 · 2016-11-23

ApplicantBiomet Microfixation
Decision Date2016-11-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Biomet Microfixation SternaLock 360 Sternal Closure 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 2016-11-23 under 510(k) number K163007. 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 SternaLock 360 Sternal Closure System?

Biomet Microfixation SternaLock 360 Sternal Closure System is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Biomet Microfixation. The 510(k) number is K163007.

When did Biomet Microfixation SternaLock 360 Sternal Closure System receive FDA 510(k) clearance?

Biomet Microfixation SternaLock 360 Sternal Closure System received FDA 510(k) clearance on 2016-11-23, under 510(k) number K163007.

Who is the listed applicant for Biomet Microfixation SternaLock 360 Sternal Closure 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 Biomet Microfixation SternaLock 360 Sternal Closure System?

The FDA product code for Biomet Microfixation SternaLock 360 Sternal Closure System is HRS.

Other records listing Biomet Microfixation as applicant

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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.

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 KGK261351SALGINA 2.5mm Distal Radius SystemBonebridge 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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