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FDA 510(k)

Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED

K-Number: K040685 · 2005-01-25

ApplicantOsteoimplant Technology, Inc.
Decision Date2005-01-25
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED 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 2005-01-25 under 510(k) number K040685. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED?

Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED is a medical device that received FDA 510(k) clearance on 2005-01-25. The listed applicant is Osteoimplant Technology, Inc.. The 510(k) number is K040685.

When did Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED receive FDA 510(k) clearance?

Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED received FDA 510(k) clearance on 2005-01-25, under 510(k) number K040685.

Who is the listed applicant for Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED?

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 Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED?

The FDA product code for Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED is LWJ.

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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.

K041443OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEMK040225OTI 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: LWJ)

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.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.

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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