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FDA 510(k)

EXACTECH FEMORAL STEM

K-Number: K925201 · 1993-06-15

ApplicantExactech, Inc.
Decision Date1993-06-15
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH FEMORAL STEM is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1993-06-15 under 510(k) number K925201. 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 EXACTECH FEMORAL STEM?

EXACTECH FEMORAL STEM is a medical device that received FDA 510(k) clearance on 1993-06-15. The listed applicant is Exactech, Inc.. The 510(k) number is K925201.

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

EXACTECH FEMORAL STEM received FDA 510(k) clearance on 1993-06-15, under 510(k) number K925201.

Who is the listed applicant for EXACTECH FEMORAL STEM?

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

What is the FDA product code for EXACTECH FEMORAL STEM?

The FDA product code for EXACTECH FEMORAL STEM is JDI.

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Other records listing Exactech, 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.

K260583Equinoxe® Shoulder SystemK250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsK243448Equinoxe® Shoulder SystemK243275Equinoxe® Scapula Fracture SystemK243839Alteon® HA Femoral StemsK240393Exactech® TRULIANT® Knee System

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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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