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)

AxSOS 3 AF System and AxSOS 3 Ti System

K-Number: K200398 · 2020-06-05

ApplicantStryker GmbH
Decision Date2020-06-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AxSOS 3 AF System and AxSOS 3 Ti System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2020-06-05 under 510(k) number K200398. 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 AxSOS 3 AF System and AxSOS 3 Ti System?

AxSOS 3 AF System and AxSOS 3 Ti System is a medical device that received FDA 510(k) clearance on 2020-06-05. The listed applicant is Stryker GmbH. The 510(k) number is K200398.

When did AxSOS 3 AF System and AxSOS 3 Ti System receive FDA 510(k) clearance?

AxSOS 3 AF System and AxSOS 3 Ti System received FDA 510(k) clearance on 2020-06-05, under 510(k) number K200398.

Who is the listed applicant for AxSOS 3 AF System and AxSOS 3 Ti System?

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

What is the FDA product code for AxSOS 3 AF System and AxSOS 3 Ti System?

The FDA product code for AxSOS 3 AF System and AxSOS 3 Ti System is HRS.

Other records listing Stryker GmbH 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.

K261481Pangea Femur Reconstruction SystemK253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemK253202Hoffmann LRF SystemK251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemK250163T2 Alpha Femur Retrograde Nailing SystemK242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System

View all 164 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.

↑