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FDA 510(k)

A.L.P.S. Clavicle Plating System

K-Number: K210192 · 2021-02-19

ApplicantBiomet, Inc.
Decision Date2021-02-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

A.L.P.S. Clavicle Plating System is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2021-02-19 under approval number K210192. 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 A.L.P.S. Clavicle Plating System?

A.L.P.S. Clavicle Plating System is a medical device that received FDA 510(k) clearance on 2021-02-19. It is manufactured by Biomet, Inc.. The 510(k) number is K210192.

When was A.L.P.S. Clavicle Plating System approved by the FDA?

A.L.P.S. Clavicle Plating System received FDA 510(k) clearance on 2021-02-19, under approval number K210192.

What company makes A.L.P.S. Clavicle Plating System?

A.L.P.S. Clavicle Plating System is manufactured by Biomet, Inc..

What is the FDA product code for A.L.P.S. Clavicle Plating System?

The FDA product code for A.L.P.S. Clavicle Plating System is HRS.

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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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