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FDA 510(k)

Dyna Locking Trochanteric Nail™

K-Number: K221084 · 2023-03-03

ApplicantInnosys
Decision Date2023-03-03
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dyna Locking Trochanteric Nail™ is the device name listed in this FDA 510(k) record. The listed applicant is Innosys. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K221084. 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 Dyna Locking Trochanteric Nail™?

Dyna Locking Trochanteric Nail™ is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Innosys. The 510(k) number is K221084.

When did Dyna Locking Trochanteric Nail™ receive FDA 510(k) clearance?

Dyna Locking Trochanteric Nail™ received FDA 510(k) clearance on 2023-03-03, under 510(k) number K221084.

Who is the listed applicant for Dyna Locking Trochanteric Nail™?

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

What is the FDA product code for Dyna Locking Trochanteric Nail™?

The FDA product code for Dyna Locking Trochanteric Nail™ is HSB.

Other records listing Innosys 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.

K241082INNOVERSE Navigation InstrumentsK234119UniSpace® Stand-Alone C CageK233960INNOVERSE Spinal SystemK231737ANAX™ 5.5 Spinal System

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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