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FDA 510(k)

CL HIP STEM H/A COATED

K-Number: K922613 · 1994-04-05

ApplicantLima Intl. Corp.
Decision Date1994-04-05
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

CL HIP STEM H/A COATED is the device name listed in this FDA 510(k) record. The listed applicant is Lima Intl. Corp.. It received FDA 510(k) clearance on 1994-04-05 under 510(k) number K922613. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the CL HIP STEM H/A COATED?

CL HIP STEM H/A COATED is a medical device that received FDA 510(k) clearance on 1994-04-05. The listed applicant is Lima Intl. Corp.. The 510(k) number is K922613.

When did CL HIP STEM H/A COATED receive FDA 510(k) clearance?

CL HIP STEM H/A COATED received FDA 510(k) clearance on 1994-04-05, under 510(k) number K922613.

Who is the listed applicant for CL HIP STEM H/A COATED?

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

What is the FDA product code for CL HIP STEM H/A COATED?

The FDA product code for CL HIP STEM H/A COATED is MEH.

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Other records listing Lima Intl. Corp. 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.

K910836LIMA COLLARED CL STEMK896851PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESECK900051MOORE TYPE ENDO PROSTHESISK902621SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENTK896850LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLEK900257MULLER TYPE ACETABULAR CUP

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Related Devices (Code: MEH)

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.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, Inc.

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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