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FDA 510(k)

APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)

K-Number: K954800 · 1996-04-25

ApplicantIntermedics Orthopedics
Decision Date1996-04-25
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1996-04-25 under 510(k) number K954800. 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 APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)?

APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) is a medical device that received FDA 510(k) clearance on 1996-04-25. The listed applicant is Intermedics Orthopedics. The 510(k) number is K954800.

When did APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) receive FDA 510(k) clearance?

APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) received FDA 510(k) clearance on 1996-04-25, under 510(k) number K954800.

Who is the listed applicant for APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)?

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

What is the FDA product code for APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)?

The FDA product code for APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) is MEH.

Related Clinical Trials

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Other records listing Intermedics Orthopedics as applicant

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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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