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FDA 510(k)

OTI FEMORAL LOCK TOTAL HIP SYSTEM

K-Number: K982598 · 1998-10-02

ApplicantOsteoimplant Technology, Inc.
Decision Date1998-10-02
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OTI FEMORAL LOCK TOTAL HIP 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 1998-10-02 under 510(k) number K982598. 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 OTI FEMORAL LOCK TOTAL HIP SYSTEM?

OTI FEMORAL LOCK TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1998-10-02. The listed applicant is Osteoimplant Technology, Inc.. The 510(k) number is K982598.

When did OTI FEMORAL LOCK TOTAL HIP SYSTEM receive FDA 510(k) clearance?

OTI FEMORAL LOCK TOTAL HIP SYSTEM received FDA 510(k) clearance on 1998-10-02, under 510(k) number K982598.

Who is the listed applicant for OTI FEMORAL LOCK TOTAL HIP 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 FEMORAL LOCK TOTAL HIP SYSTEM?

The FDA product code for OTI FEMORAL LOCK TOTAL HIP SYSTEM is JDI.

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Other records listing Osteoimplant Technology, Inc. as applicant

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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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