Parcus GFS BTB

Fastener, Fixation, Nondegradable, Soft Tissue

Parcus Medical, LLC

The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus Gfs Btb.

Pre-market Notification Details

Device IDK183331
510k NumberK183331
Device Name:Parcus GFS BTB
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Parcus Medical, LLC 6423 Parkland Dr Sarasota,  FL  34243
ContactPaul Vagts
CorrespondentPaul Vagts
Parcus Medical, LLC 6423 Parkland Dr Sarasota,  FL  34243
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-03
Decision Date2019-02-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816342024976 K183331 000

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