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FDA 510(k)

SELF-ALIGNING ACETABULAR COMPONENT

K-Number: K831792 · 1984-09-20

ApplicantEndomedics, Inc.
Decision Date1984-09-20
Product CodeJDL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SELF-ALIGNING 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 1984-09-20 under 510(k) number K831792. The device is classified under product code JDL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELF-ALIGNING ACETABULAR COMPONENT?

SELF-ALIGNING ACETABULAR COMPONENT is a medical device that received FDA 510(k) clearance on 1984-09-20. The listed applicant is Endomedics, Inc.. The 510(k) number is K831792.

When did SELF-ALIGNING ACETABULAR COMPONENT receive FDA 510(k) clearance?

SELF-ALIGNING ACETABULAR COMPONENT received FDA 510(k) clearance on 1984-09-20, under 510(k) number K831792.

Who is the listed applicant for SELF-ALIGNING 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 SELF-ALIGNING ACETABULAR COMPONENT?

The FDA product code for SELF-ALIGNING ACETABULAR COMPONENT is JDL.

Related Clinical Trials

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.

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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.

K842233NEW JERSEY FEMORAL RESURFACING COMPONENTK842202NEW JERSEY ACETABULAR COMPONENT &K842234NEW JERSEY FEMORAL STEM

Related Devices (Code: JDL)

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.

K073499VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIESZimmer, Inc.K070785DYNASTY ACETABULAR SYSTEMWrightmedicaltechnologyincK061844DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINERWrightmedicaltechnologyincK051995PROFEMUR RENAISSANCE HIP STEMWrightmedicaltechnologyincK051348CONSERVE TOTAL FEMORAL HEADWrightmedicaltechnologyincK042841M2A/C2A ACETABULAR SYSTEMBiomet, Inc.

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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