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FDA 510(k)

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System

K-Number: K213328 · 2022-02-11

ApplicantStryker GmbH
Decision Date2022-02-11
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing 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 2022-02-11 under 510(k) number K213328. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System?

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System is a medical device that received FDA 510(k) clearance on 2022-02-11. The listed applicant is Stryker GmbH. The 510(k) number is K213328.

When did Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System receive FDA 510(k) clearance?

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System received FDA 510(k) clearance on 2022-02-11, under 510(k) number K213328.

Who is the listed applicant for Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing 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 Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System?

The FDA product code for Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System is HSB.

Other records listing Stryker GmbH as applicant

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Related Devices (Code: HSB)

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 SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

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.

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