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FDA 510(k)

ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS

K-Number: K053587 · 2006-03-17

ApplicantOrtho Development Corp.
Decision Date2006-03-17
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 2006-03-17 under 510(k) number K053587. 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 ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS?

ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS is a medical device that received FDA 510(k) clearance on 2006-03-17. The listed applicant is Ortho Development Corp.. The 510(k) number is K053587.

When did ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS receive FDA 510(k) clearance?

ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS received FDA 510(k) clearance on 2006-03-17, under 510(k) number K053587.

Who is the listed applicant for ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS?

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

What is the FDA product code for ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS?

The FDA product code for ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS is LZO.

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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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