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FDA 510(k)

HOWMEDICA(R) HNR SYSTEM

K-Number: K922503 · 1992-09-21

ApplicantHowmedica Corp.
Decision Date1992-09-21
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOWMEDICA(R) HNR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1992-09-21 under 510(k) number K922503. 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(R) HNR SYSTEM?

HOWMEDICA(R) HNR SYSTEM is a medical device that received FDA 510(k) clearance on 1992-09-21. The listed applicant is Howmedica Corp.. The 510(k) number is K922503.

When did HOWMEDICA(R) HNR SYSTEM receive FDA 510(k) clearance?

HOWMEDICA(R) HNR SYSTEM received FDA 510(k) clearance on 1992-09-21, under 510(k) number K922503.

Who is the listed applicant for HOWMEDICA(R) HNR SYSTEM?

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

What is the FDA product code for HOWMEDICA(R) HNR SYSTEM?

The FDA product code for HOWMEDICA(R) HNR SYSTEM is JDI.

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Other records listing Howmedica Corp. as applicant

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Related Devices (Code: JDI)

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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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