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FDA 510(k)

APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM

K-Number: K905781 · 1991-03-04

ApplicantIntermedics Orthopedics
Decision Date1991-03-04
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1991-03-04 under 510(k) number K905781. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM?

APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1991-03-04. The listed applicant is Intermedics Orthopedics. The 510(k) number is K905781.

When did APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM receive FDA 510(k) clearance?

APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM received FDA 510(k) clearance on 1991-03-04, under 510(k) number K905781.

Who is the listed applicant for APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM?

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 AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM?

The FDA product code for APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM is MEH.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Intermedics Orthopedics 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.

K970300NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTIK970498NATURAL-KNEE II REVISION FEMORAL SPACER LUGSK970166NATURAL-HIP SYSTEM COCR REVISION STEMK970567SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDSK964357NATURAL-HIP SYSTEM COCR STEMK964350MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA

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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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