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FDA 510(k)

OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM

K-Number: K041443 · 2004-11-16

ApplicantOsteoimplant Technology, Inc.
Decision Date2004-11-16
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteoimplant Technology, Inc.. It received FDA 510(k) clearance on 2004-11-16 under 510(k) number K041443. 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 OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM?

OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM is a medical device that received FDA 510(k) clearance on 2004-11-16. The listed applicant is Osteoimplant Technology, Inc.. The 510(k) number is K041443.

When did OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM receive FDA 510(k) clearance?

OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM received FDA 510(k) clearance on 2004-11-16, under 510(k) number K041443.

Who is the listed applicant for OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM?

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

What is the FDA product code for OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM?

The FDA product code for OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM is LZO.

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Other records listing Osteoimplant Technology, Inc. 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.

K040685Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATEDK040225OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEMK032729Z-SERIES MODULAR TOTAL HIP SYSTEMK030608OTI BONE CEMENT PLUGK022779OTI UNICONDULAR INTERPOSITIONAL SPACERK021822R120 MODULAR TOTAL HIP SYSTEM

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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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