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FDA 510(k)

Baby Gorilla/Gorilla Plating System; Monster Screw System

K-Number: K241262 · 2024-06-05

ApplicantParagon 28, Inc.
Decision Date2024-06-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Baby Gorilla/Gorilla Plating System; Monster Screw System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2024-06-05 under approval number K241262. 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 Baby Gorilla/Gorilla Plating System; Monster Screw System?

Baby Gorilla/Gorilla Plating System; Monster Screw System is a medical device that received FDA 510(k) clearance on 2024-06-05. It is manufactured by Paragon 28, Inc.. The 510(k) number is K241262.

When was Baby Gorilla/Gorilla Plating System; Monster Screw System approved by the FDA?

Baby Gorilla/Gorilla Plating System; Monster Screw System received FDA 510(k) clearance on 2024-06-05, under approval number K241262.

What company makes Baby Gorilla/Gorilla Plating System; Monster Screw System?

Baby Gorilla/Gorilla Plating System; Monster Screw System is manufactured by Paragon 28, Inc..

What is the FDA product code for Baby Gorilla/Gorilla Plating System; Monster Screw System?

The FDA product code for Baby Gorilla/Gorilla Plating System; Monster Screw System is HRS.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING NCT07511478 Fibula Plating vs Intramedullary K-Wire in Bimalleolar Ankle Fractures COMPLETED

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

Other Devices by Paragon 28, Inc.

K170693Phantom Small Bone Intramedullary Nail System K182148SILVERBACK Gorilla Plating System K191782TTC Phantom Intramedullary Nail System K190365Baby Gorilla/Gorilla Plating System K190586Monster® Screw System K183690Tenodesis Screw 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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