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FDA 510(k)

APR II FEMORAL COMPONENT (VARIOUS)

K-Number: K942330 · 1994-10-04

ApplicantIntermedics Orthopedics
Decision Date1994-10-04
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

APR II FEMORAL COMPONENT (VARIOUS) is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1994-10-04 under 510(k) number K942330. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the APR II FEMORAL COMPONENT (VARIOUS)?

APR II FEMORAL COMPONENT (VARIOUS) is a medical device that received FDA 510(k) clearance on 1994-10-04. The listed applicant is Intermedics Orthopedics. The 510(k) number is K942330.

When did APR II FEMORAL COMPONENT (VARIOUS) receive FDA 510(k) clearance?

APR II FEMORAL COMPONENT (VARIOUS) received FDA 510(k) clearance on 1994-10-04, under 510(k) number K942330.

Who is the listed applicant for APR II FEMORAL COMPONENT (VARIOUS)?

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 II FEMORAL COMPONENT (VARIOUS)?

The FDA product code for APR II FEMORAL COMPONENT (VARIOUS) is LZO.

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: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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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