COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM

Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

BIOMET ORTHOPEDICS LLC.

The following data is part of a premarket notification filed by Biomet Orthopedics Llc. with the FDA for Compress(r) Segmental Humeral Replacement System.

Pre-market Notification Details

Device IDK112905
510k NumberK112905
Device Name:COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Applicant BIOMET ORTHOPEDICS LLC. P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactGary Baker
CorrespondentGary Baker
BIOMET ORTHOPEDICS LLC. P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeMBF  
Subsequent Product CodeJDC
Subsequent Product CodeKWS
Subsequent Product CodeKWT
CFR Regulation Number888.3670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-03
Decision Date2012-05-24
Summary:summary

NIH GUDID Devices

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