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)

Stryker SonicPin System

K-Number: K170418 · 2017-06-20

ApplicantStryker Trauma GmbH
Decision Date2017-06-20
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stryker SonicPin System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Trauma GmbH. It received FDA 510(k) clearance on 2017-06-20 under 510(k) number K170418. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker SonicPin System?

Stryker SonicPin System is a medical device that received FDA 510(k) clearance on 2017-06-20. The listed applicant is Stryker Trauma GmbH. The 510(k) number is K170418.

When did Stryker SonicPin System receive FDA 510(k) clearance?

Stryker SonicPin System received FDA 510(k) clearance on 2017-06-20, under 510(k) number K170418.

Who is the listed applicant for Stryker SonicPin System?

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

What is the FDA product code for Stryker SonicPin System?

The FDA product code for Stryker SonicPin System is HTY.

Other records listing Stryker Trauma 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.

K200869Gamma3 SystemK193308T2 Alpha Tibia Nailing System, IMN Screws SystemK191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments SystemK180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemK172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemK172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

View all 7 devices →

Related Devices (Code: HTY)

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.

K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical TechnologiesK241014Biomet Kirschner Wires (K-Wires)Biomet, Inc.

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.

↑