ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM

Shoulder Prosthesis, Reverse Configuration

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm And 10mm.

Pre-market Notification Details

Device IDK060704
510k NumberK060704
Device Name:ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactDalene T Binkley
CorrespondentDalene T Binkley
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
Subsequent Product CodeKWT
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-16
Decision Date2006-05-19
Summary:summary

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