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FDA 510(k)

NEW JERSEY ACETABULAR COMPONENT &

K-Number: K842202 · 1984-07-20

ApplicantEndomedics, Inc.
Decision Date1984-07-20
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEW JERSEY ACETABULAR COMPONENT & is the device name listed in this FDA 510(k) record. The listed applicant is Endomedics, Inc.. It received FDA 510(k) clearance on 1984-07-20 under 510(k) number K842202. 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 NEW JERSEY ACETABULAR COMPONENT &?

NEW JERSEY ACETABULAR COMPONENT & is a medical device that received FDA 510(k) clearance on 1984-07-20. The listed applicant is Endomedics, Inc.. The 510(k) number is K842202.

When did NEW JERSEY ACETABULAR COMPONENT & receive FDA 510(k) clearance?

NEW JERSEY ACETABULAR COMPONENT & received FDA 510(k) clearance on 1984-07-20, under 510(k) number K842202.

Who is the listed applicant for NEW JERSEY ACETABULAR COMPONENT &?

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

What is the FDA product code for NEW JERSEY ACETABULAR COMPONENT &?

The FDA product code for NEW JERSEY ACETABULAR COMPONENT & is JDI.

Related Clinical Trials

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Other records listing Endomedics, 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.

K831792SELF-ALIGNING ACETABULAR COMPONENTK842233NEW JERSEY FEMORAL RESURFACING COMPONENTK842234NEW JERSEY FEMORAL STEM

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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