3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM

Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

BIOMET ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for 3-piece Proximal Humeral Replacement System.

Pre-market Notification Details

Device IDK020045
510k NumberK020045
Device Name:3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM
ClassificationProsthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Applicant BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactDalene T Binkley
CorrespondentDalene T Binkley
BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeKWT  
CFR Regulation Number888.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-07
Decision Date2002-01-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304370500 K020045 000
00880304215689 K020045 000
00880304215696 K020045 000
00880304215702 K020045 000
00880304215719 K020045 000
00880304215726 K020045 000
00880304370463 K020045 000
00880304370470 K020045 000
00880304370487 K020045 000
00880304370494 K020045 000
00880304215672 K020045 000

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