NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural-knee Tibial Baseplate/all Poly Patella.

Pre-market Notification Details

Device IDK934695
510k NumberK934695
Device Name:NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
ContactMitchell Dhority
CorrespondentMitchell Dhority
INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-30
Decision Date1996-05-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024257757 K934695 000

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