NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM

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

NEXA ORTHOPEDICS, INC.

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

Pre-market Notification Details

Device IDK071147
510k NumberK071147
Device Name:NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM
ClassificationProsthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Applicant NEXA ORTHOPEDICS, INC. 49 PLAIN ST. North Attleboro,  MA  02760
ContactMary Mcnamara-cullinane
CorrespondentMary Mcnamara-cullinane
NEXA ORTHOPEDICS, INC. 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeKWT  
CFR Regulation Number888.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-24
Decision Date2007-07-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00846832004386 K071147 000
00846832004065 K071147 000
00846832004089 K071147 000
00846832004102 K071147 000
00846832004126 K071147 000
00846832004140 K071147 000
00846832004164 K071147 000
00846832004188 K071147 000
00846832004201 K071147 000
00846832004225 K071147 000
00846832004249 K071147 000
00846832004263 K071147 000
00846832004287 K071147 000
00846832004300 K071147 000
00846832004324 K071147 000
00846832004348 K071147 000
00846832004362 K071147 000
00846832004041 K071147 000

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