Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm

Fastener, Fixation, Nondegradable, Soft Tissue

Dunamis LLC

The following data is part of a premarket notification filed by Dunamis Llc with the FDA for Dunamis Suture Anchor Peek 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm.

Pre-market Notification Details

Device IDK160996
510k NumberK160996
Device Name:Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Dunamis LLC 693 Sherling Lake Rd Apt 122 Greenville,  AL  36037
ContactPrithvi Raj Chavan
CorrespondentRobert O. Dean
LexaMed 705 Front St. Toledo,  OH  43605
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-08
Decision Date2016-07-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00854629006321 K160996 000

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