NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW

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 Congruent Tibial Insert With Screw.

Pre-market Notification Details

Device IDK931651
510k NumberK931651
Device Name:NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactJoann Ringer
CorrespondentJoann Ringer
INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-05
Decision Date1994-07-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024257627 K931651 000

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