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FDA 510(k)

PARAGON HIP SYSTEM

K-Number: K123782 · 2013-03-14

ApplicantGlobal Manufacturing Technology
Decision Date2013-03-14
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PARAGON HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Global Manufacturing Technology. It received FDA 510(k) clearance on 2013-03-14 under 510(k) number K123782. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAGON HIP SYSTEM?

PARAGON HIP SYSTEM is a medical device that received FDA 510(k) clearance on 2013-03-14. The listed applicant is Global Manufacturing Technology. The 510(k) number is K123782.

When did PARAGON HIP SYSTEM receive FDA 510(k) clearance?

PARAGON HIP SYSTEM received FDA 510(k) clearance on 2013-03-14, under 510(k) number K123782.

Who is the listed applicant for PARAGON HIP SYSTEM?

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

What is the FDA product code for PARAGON HIP SYSTEM?

The FDA product code for PARAGON HIP SYSTEM is LZO.

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 Global Manufacturing Technology 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.

K113107MSA HIP SYSTEMK102172MSA HIP SYSTEM

Related Devices (Code: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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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