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FDA 510(k)

DRPx Locking Distal Radius Plate System

K-Number: K212601 · 2022-04-05

ApplicantOrthopaedic Implant Company
Decision Date2022-04-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DRPx Locking Distal Radius Plate System is a medical device manufactured by Orthopaedic Implant Company. It received FDA 510(k) clearance on 2022-04-05 under approval number K212601. 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 DRPx Locking Distal Radius Plate System?

DRPx Locking Distal Radius Plate System is a medical device that received FDA 510(k) clearance on 2022-04-05. It is manufactured by Orthopaedic Implant Company. The 510(k) number is K212601.

When was DRPx Locking Distal Radius Plate System approved by the FDA?

DRPx Locking Distal Radius Plate System received FDA 510(k) clearance on 2022-04-05, under approval number K212601.

What company makes DRPx Locking Distal Radius Plate System?

DRPx Locking Distal Radius Plate System is manufactured by Orthopaedic Implant Company.

What is the FDA product code for DRPx Locking Distal Radius Plate System?

The FDA product code for DRPx Locking Distal Radius Plate System is HRS.

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Other Devices by Orthopaedic Implant Company

K171211OIC External Fixation System K183682OIC External Fixation System K202971DRPx Locking Distal Radius Plate System K211112OIC External Fixation System K223761OIC Intramedullary Screw System K223118OIC Variable Angle Small Fragment Locking Plate 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 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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