ACUMED MODULAR SHOULDER SYSTEM

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

ACUMED, INC.

The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Acumed Modular Shoulder System.

Pre-market Notification Details

Device IDK992525
510k NumberK992525
Device Name:ACUMED MODULAR SHOULDER SYSTEM
ClassificationProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
ContactShari Jeffers
CorrespondentShari Jeffers
ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
Product CodeHSD  
CFR Regulation Number888.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-28
Decision Date2000-02-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10806378084683 K992525 000
10806378084676 K992525 000
10806378083716 K992525 000
10806378083709 K992525 000
10806378082610 K992525 000
10806378082603 K992525 000

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