Akros FibuLink™ Syndesmosis Repair Kit

Washer, Bolt Nut

Akros Medical

The following data is part of a premarket notification filed by Akros Medical with the FDA for Akros Fibulink™ Syndesmosis Repair Kit.

Pre-market Notification Details

Device IDK173550
510k NumberK173550
Device Name:Akros FibuLink™ Syndesmosis Repair Kit
ClassificationWasher, Bolt Nut
Applicant Akros Medical 3503 Pleasant Green Rd Durham,  NC  27705
ContactCharles Horrell
CorrespondentCharles Horrell
Akros Medical 3503 Pleasant Green Rd Durham,  NC  27705
Product CodeHTN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-16
Decision Date2017-12-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00863176000317 K173550 000

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