THREADED PEEK K-WIRE

Fastener, Fixation, Nondegradable, Soft Tissue

MTP SOLUTIONS LLC

The following data is part of a premarket notification filed by Mtp Solutions Llc with the FDA for Threaded Peek K-wire.

Pre-market Notification Details

Device IDK133235
510k NumberK133235
Device Name:THREADED PEEK K-WIRE
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant MTP SOLUTIONS LLC 124 SOUTH 600 WEST, SUITE 100 Logan,  UT  84321
ContactRobert Hoy
CorrespondentRobert Hoy
MTP SOLUTIONS LLC 124 SOUTH 600 WEST, SUITE 100 Logan,  UT  84321
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-21
Decision Date2014-04-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885554034899 K133235 000

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