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FDA 510(k)

SternaLock Sternal Closure System

K-Number: K212782 · 2022-05-17

ApplicantBiomet Microfixation
Decision Date2022-05-17
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SternaLock Sternal Closure System is a medical device manufactured by Biomet Microfixation. It received FDA 510(k) clearance on 2022-05-17 under approval number K212782. 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 SternaLock Sternal Closure System?

SternaLock Sternal Closure System is a medical device that received FDA 510(k) clearance on 2022-05-17. It is manufactured by Biomet Microfixation. The 510(k) number is K212782.

When was SternaLock Sternal Closure System approved by the FDA?

SternaLock Sternal Closure System received FDA 510(k) clearance on 2022-05-17, under approval number K212782.

What company makes SternaLock Sternal Closure System?

SternaLock Sternal Closure System is manufactured by Biomet Microfixation.

What is the FDA product code for SternaLock Sternal Closure System?

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

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Other Devices by Biomet Microfixation

K162974Biomet Microfixation RibFix Blu Thoracic Fixation System K163007Biomet Microfixation SternaLock 360 Sternal Closure System K161896Biomet Microfixation Sternal Closure System K152253Biomet Microfixation RibFix Blu Thoracic Fixation System K190576WalterLorenz Surgical Assist Arm Scope Holder K213208Twist Drills

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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 K163007Biomet Microfixation SternaLock 360 Sternal Closure 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

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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