ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Segmental System Proximal Femoral Component And Small Diameter Stem Extensions.

Pre-market Notification Details

Device IDK101296
510k NumberK101296
Device Name:ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactChristina Forney
CorrespondentChristina Forney
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeLZO  
Subsequent Product CodeJDI
Subsequent Product CodeKRO
Subsequent Product CodeKWL
Subsequent Product CodeKWY
Subsequent Product CodeKWZ
Subsequent Product CodeLPH
Subsequent Product CodeLWJ
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-05-10
Decision Date2010-07-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00889024197282 K101296 000

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