NeoSpan Compression Staple Impant W/instruments

Staple, Fixation, Bone

IN2BONESUSA, LLC

The following data is part of a premarket notification filed by In2bonesusa, Llc with the FDA for Neospan Compression Staple Impant W/instruments.

Pre-market Notification Details

Device IDK161426
510k NumberK161426
Device Name:NeoSpan Compression Staple Impant W/instruments
ClassificationStaple, Fixation, Bone
Applicant IN2BONESUSA, LLC 6060 POPLAR AVE, SUITE 380 Memphis,  TN  38119
ContactJoe Clift
CorrespondentLouise Focht
ENMED INTERNATIONAL, INC PO BOX 249 Del Mar,  CA  92014
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-23
Decision Date2016-10-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817906020182 K161426 000
00810021861371 K161426 000
00817906020076 K161426 000
00817906020083 K161426 000
00817906020090 K161426 000
00817906020106 K161426 000
00817906020113 K161426 000
00817906020120 K161426 000
00817906020137 K161426 000
00817906020144 K161426 000
00817906020151 K161426 000
00817906020168 K161426 000
00817906020175 K161426 000
00810021861364 K161426 000

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