MICRONAIL Distal Radius System

Rod, Fixation, Intramedullary And Accessories

Wright Medical Technology, Inc.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Micronail Distal Radius System.

Pre-market Notification Details

Device IDK150073
510k NumberK150073
Device Name:MICRONAIL Distal Radius System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant Wright Medical Technology, Inc. 1023 Cherry Road Memphis,  TN  38117
ContactJeanine Redden
CorrespondentJeanine Redden
Wright Medical Technology, Inc. 1023 Cherry Road Memphis,  TN  38117
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-14
Decision Date2015-02-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420123787 K150073 000
00840420118943 K150073 000
00840420118950 K150073 000
00840420118967 K150073 000
00840420118974 K150073 000
00840420118981 K150073 000
00840420118998 K150073 000
00840420119001 K150073 000
00840420119018 K150073 000
00840420119025 K150073 000
00840420119032 K150073 000
00840420119049 K150073 000
00840420119056 K150073 000
00840420123749 K150073 000
00840420123756 K150073 000
00840420123763 K150073 000
00840420123770 K150073 000
00840420118936 K150073 000

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