ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS

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

MATERIALISE N.V.

The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific Instruments.

Pre-market Notification Details

Device IDK111492
510k NumberK111492
Device Name:ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven,  BE 3001
ContactAlexandra Razzhivina
CorrespondentAlexandra Razzhivina
MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven,  BE 3001
Product CodeJWH  
Subsequent Product CodeMBH
Subsequent Product CodeOOG
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-31
Decision Date2011-10-13
Summary:summary

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