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

FDA 510(k)

OrthoPediatrics PediFoot Deformity Corrections System

K-Number: K190992 · 2019-08-06

ApplicantOrthoPediatrics Corp.
Decision Date2019-08-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OrthoPediatrics PediFoot Deformity Corrections System is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2019-08-06 under 510(k) number K190992. 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 OrthoPediatrics PediFoot Deformity Corrections System?

OrthoPediatrics PediFoot Deformity Corrections System is a medical device that received FDA 510(k) clearance on 2019-08-06. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K190992.

When did OrthoPediatrics PediFoot Deformity Corrections System receive FDA 510(k) clearance?

OrthoPediatrics PediFoot Deformity Corrections System received FDA 510(k) clearance on 2019-08-06, under 510(k) number K190992.

Who is the listed applicant for OrthoPediatrics PediFoot Deformity Corrections System?

The FDA 510(k) record lists OrthoPediatrics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OrthoPediatrics PediFoot Deformity Corrections System?

The FDA product code for OrthoPediatrics PediFoot Deformity Corrections System is HRS.

Other records listing OrthoPediatrics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemK252600Pediatric Plating Platform I Small-MiniK251362PediFlex™ Flexible Nail SystemK243963Pediatric Plating Platform HipK250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurK241816VerteGlide Spinal Growth Guidance System

View all 27 devices →

Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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.

↑