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FDA 510(k)

ACE PROXIMAL HUMERAL NAIL SYSTEM

K-Number: K033806 · 2004-02-20

ApplicantDepuy Ace
Decision Date2004-02-20
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACE PROXIMAL HUMERAL NAIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ace. It received FDA 510(k) clearance on 2004-02-20 under 510(k) number K033806. 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 ACE PROXIMAL HUMERAL NAIL SYSTEM?

ACE PROXIMAL HUMERAL NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 2004-02-20. The listed applicant is Depuy Ace. The 510(k) number is K033806.

When did ACE PROXIMAL HUMERAL NAIL SYSTEM receive FDA 510(k) clearance?

ACE PROXIMAL HUMERAL NAIL SYSTEM received FDA 510(k) clearance on 2004-02-20, under 510(k) number K033806.

Who is the listed applicant for ACE PROXIMAL HUMERAL NAIL SYSTEM?

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

What is the FDA product code for ACE PROXIMAL HUMERAL NAIL SYSTEM?

The FDA product code for ACE PROXIMAL HUMERAL NAIL SYSTEM is HSB.

Related Clinical Trials

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.

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Other records listing Depuy Ace 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.

K033878ACE ANTEGRADE RETROGRADE HUMERAL NAIL 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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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