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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 a medical device manufactured by Biomet Microfixation. It received FDA 510(k) clearance on 2016-11-23 under approval 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. It is manufactured by Biomet Microfixation. The 510(k) number is K163007.

When was Biomet Microfixation SternaLock 360 Sternal Closure System approved by the FDA?

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

What company makes Biomet Microfixation SternaLock 360 Sternal Closure System?

Biomet Microfixation SternaLock 360 Sternal Closure System is manufactured by Biomet Microfixation.

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.

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Other Devices by Biomet Microfixation

K162974Biomet Microfixation RibFix Blu Thoracic Fixation System K161896Biomet Microfixation Sternal Closure System K152253Biomet Microfixation RibFix Blu Thoracic Fixation System K190576WalterLorenz Surgical Assist Arm Scope Holder K213208Twist Drills K202969Biomet Microfixation OmniMax MMF System

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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 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 K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.

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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