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FDA 510(k)

OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS

K-Number: K960647 · 1996-09-17

ApplicantOsteoimplant Technology, Inc.
Decision Date1996-09-17
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS 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 1996-09-17 under 510(k) number K960647. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS?

OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS is a medical device that received FDA 510(k) clearance on 1996-09-17. The listed applicant is Osteoimplant Technology, Inc.. The 510(k) number is K960647.

When did OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS receive FDA 510(k) clearance?

OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS received FDA 510(k) clearance on 1996-09-17, under 510(k) number K960647.

Who is the listed applicant for OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS?

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 OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS?

The FDA product code for OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS is JDI.

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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: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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