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FDA 510(k)

INTERMEDICS APR(TM) II FEMORAL COMPONENT

K-Number: K890450 · 1989-08-09

ApplicantIntermedics Orthopedics
Decision Date1989-08-09
Product CodeJDJ
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

INTERMEDICS APR(TM) II FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1989-08-09 under 510(k) number K890450. The device is classified under product code JDJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the INTERMEDICS APR(TM) II FEMORAL COMPONENT?

INTERMEDICS APR(TM) II FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1989-08-09. The listed applicant is Intermedics Orthopedics. The 510(k) number is K890450.

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

INTERMEDICS APR(TM) II FEMORAL COMPONENT received FDA 510(k) clearance on 1989-08-09, under 510(k) number K890450.

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

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 INTERMEDICS APR(TM) II FEMORAL COMPONENT?

The FDA product code for INTERMEDICS APR(TM) II FEMORAL COMPONENT is JDJ.

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 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: JDJ)

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.

K972760LINK, ACETABULAR REVISION MESH CUPLink America, Inc.K970957OSTEONICS RESTORATION ACETABULAR RINGOsteonics Corp.K963940EXETER MESHHowmedica, Inc.K962541REFLECTION ACETABULAR REINFORCEMENT RINGSSmith & Nephew Richards, Inc.K962007PROTRUSION CAGESDepuy, Inc.K925883OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTSOsteonics Corp.

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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