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FDA 510(k)

FUTURA FEMORAL HIP STEM

K-Number: K910093 · 1991-07-01

ApplicantO'Tec Corp.
Decision Date1991-07-01
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FUTURA FEMORAL HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is O'Tec Corp.. It received FDA 510(k) clearance on 1991-07-01 under 510(k) number K910093. 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 FUTURA FEMORAL HIP STEM?

FUTURA FEMORAL HIP STEM is a medical device that received FDA 510(k) clearance on 1991-07-01. The listed applicant is O'Tec Corp.. The 510(k) number is K910093.

When did FUTURA FEMORAL HIP STEM receive FDA 510(k) clearance?

FUTURA FEMORAL HIP STEM received FDA 510(k) clearance on 1991-07-01, under 510(k) number K910093.

Who is the listed applicant for FUTURA FEMORAL HIP STEM?

The FDA 510(k) record lists O'Tec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUTURA FEMORAL HIP STEM?

The FDA product code for FUTURA FEMORAL HIP STEM is JDI.

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Other records listing O'Tec Corp. 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.

K943293SCC22/ SCC26 SHOWER COMMODE CHAIRK905333U.S. TYPE CRUCIATE SLOT BONE SCREWK905355BROAD SELF-COMPRESSING PLATEK905357CORTICAL BONE SCREW (EUROPEAN STYLE)K905358CANCELLOUS SCREWK905347HAGIE PIN

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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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