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FDA 510(k)

HOWMEDICA PREMIUM FEMORAL COMPONENT

K-Number: K936127 · 1994-10-26

ApplicantHowmedica, Inc.
Decision Date1994-10-26
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOWMEDICA PREMIUM FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica, Inc.. It received FDA 510(k) clearance on 1994-10-26 under 510(k) number K936127. 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 HOWMEDICA PREMIUM FEMORAL COMPONENT?

HOWMEDICA PREMIUM FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1994-10-26. The listed applicant is Howmedica, Inc.. The 510(k) number is K936127.

When did HOWMEDICA PREMIUM FEMORAL COMPONENT receive FDA 510(k) clearance?

HOWMEDICA PREMIUM FEMORAL COMPONENT received FDA 510(k) clearance on 1994-10-26, under 510(k) number K936127.

Who is the listed applicant for HOWMEDICA PREMIUM FEMORAL COMPONENT?

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

What is the FDA product code for HOWMEDICA PREMIUM FEMORAL COMPONENT?

The FDA product code for HOWMEDICA PREMIUM FEMORAL COMPONENT is JDI.

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Other records listing Howmedica, 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.

K984251XIA SPINE SYSTEMK984202HOWMEDICA HUMERAL INTERCALARY SYSTEMK984305ZETA MULTIZONE LOCKING NAIL SYSTEMK983885BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATESK983358G/K SFN AND STN LOCKING NAILSK982463EXTRACRANIAL RADIOTHERAPY 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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