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FDA 510(k)

OTI CERAMIC FEMORAL HEAD SYSTEM

K-Number: K003316 · 2001-01-19

ApplicantOsteoimplant Technology, Inc.
Decision Date2001-01-19
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OTI 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 2001-01-19 under 510(k) number K003316. 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 CERAMIC FEMORAL HEAD SYSTEM?

OTI CERAMIC FEMORAL HEAD SYSTEM is a medical device that received FDA 510(k) clearance on 2001-01-19. The listed applicant is Osteoimplant Technology, Inc.. The 510(k) number is K003316.

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

OTI CERAMIC FEMORAL HEAD SYSTEM received FDA 510(k) clearance on 2001-01-19, under 510(k) number K003316.

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

The FDA product code for OTI 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 COATEDK041443OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEMK040225OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEMK032729Z-SERIES MODULAR TOTAL HIP SYSTEMK030608OTI BONE CEMENT PLUGK022779OTI UNICONDULAR INTERPOSITIONAL SPACER

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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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