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FDA 510(k)

BIOMETRIC TOTAL HIP SYSTEM

K-Number: K935012 · 1994-03-07

ApplicantOsteo-Technology Intl., Inc.
Decision Date1994-03-07
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOMETRIC TOTAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteo-Technology Intl., Inc.. It received FDA 510(k) clearance on 1994-03-07 under 510(k) number K935012. 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 BIOMETRIC TOTAL HIP SYSTEM?

BIOMETRIC TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-07. The listed applicant is Osteo-Technology Intl., Inc.. The 510(k) number is K935012.

When did BIOMETRIC TOTAL HIP SYSTEM receive FDA 510(k) clearance?

BIOMETRIC TOTAL HIP SYSTEM received FDA 510(k) clearance on 1994-03-07, under 510(k) number K935012.

Who is the listed applicant for BIOMETRIC TOTAL HIP SYSTEM?

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

What is the FDA product code for BIOMETRIC TOTAL HIP SYSTEM?

The FDA product code for BIOMETRIC TOTAL HIP SYSTEM is JDI.

Related Clinical Trials

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Other records listing Osteo-Technology Intl., 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.

K951741REPLICA TOTAL HIP SYSTEMK925571OTI EUROPEAN COMPRESSION SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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