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)

Stratum™ Reduced Size Foot Plating System

K-Number: K200785 · 2020-07-27

ApplicantNextremity Solutions, Inc.
Decision Date2020-07-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stratum™ Reduced Size Foot Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2020-07-27 under 510(k) number K200785. 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 Stratum™ Reduced Size Foot Plating System?

Stratum™ Reduced Size Foot Plating System is a medical device that received FDA 510(k) clearance on 2020-07-27. The listed applicant is Nextremity Solutions, Inc.. The 510(k) number is K200785.

When did Stratum™ Reduced Size Foot Plating System receive FDA 510(k) clearance?

Stratum™ Reduced Size Foot Plating System received FDA 510(k) clearance on 2020-07-27, under 510(k) number K200785.

Who is the listed applicant for Stratum™ Reduced Size Foot Plating System?

The FDA 510(k) record lists Nextremity Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stratum™ Reduced Size Foot Plating System?

The FDA product code for Stratum™ Reduced Size Foot Plating System is HRS.

Other records listing Nextremity Solutions, Inc. 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.

K221610Nextra CH Cannulated Hammertoe SystemK212979CalcShift™ Displacement Calcaneal Osteotomy SystemK220181StealthFix Intraosseous Fixation SystemK213301InCore Subtalar SystemK213530Nextra CH Cannulated Hammertoe SystemK212640Stratum® Ankle Fusion Plating System

View all 14 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.

↑