Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Baby Gorilla/Gorilla Plating System

K-Number: K221465 · 2022-06-17

ApplicantParagon 28, Inc.
Decision Date2022-06-17
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Baby Gorilla/Gorilla Plating System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2022-06-17 under approval number K221465. 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?

Baby Gorilla/Gorilla Plating System is a medical device that received FDA 510(k) clearance on 2022-06-17. It is manufactured by Paragon 28, Inc.. The 510(k) number is K221465.

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

Baby Gorilla/Gorilla Plating System received FDA 510(k) clearance on 2022-06-17, under approval number K221465.

What company makes Baby Gorilla/Gorilla Plating System?

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

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

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

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

View all 50 devices →

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.

↑