FDA.reportPublic FDA data

Dunamis Medical LLC

Matched from indexed company URL: Dunamis LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30110612373011061237Dunamis Medical LLC1N2026-01-01104 Camellia Ave Suite B Greenville AL US 36037

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850052601270Constrictor® 2.0 Syndesmosis Repair Kit - Constrictor® 2.0Syndesmosis Repair Kit877.454.2186info@dunamismedical.com
00850052601317Olecranon Transporter™ Repair Kit - OL-2000877.454.2186info@dunamismedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1731901197709896K250867Dunamis Screw and Suture Locking SystemHWC2025-08-15
1731901439644435K250867Dunamis Screw and Suture Locking SystemHWC2025-08-15
1731901402094163K193245Dunamis PunchTac Suture AnchorsMBI2020-02-14
1731901005360668K192490Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchGAT2020-03-30
1731901873715928K191319Dunamis Fixation Button SystemMBI2019-08-29
1731901081617734K172016Force Fiber Fusion SutureGAT2017-10-03
1731901964842252K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmMBI2016-07-06
1731901522111519K160655OrthoButton CLMBI2016-06-03
1731901592964420K153746Dunamis Force DFX Tensile TapeGAT2016-03-03
1731901873881295K151220Dunamis Interference ScrewMBI2015-10-14
1731901567304045K150327Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2GAT2015-06-29
1731901014143949
1731901114045721
1731901181846215
1731901281886169
1731901402909025
1731901763189148
1731901798454332
1731901898289245
1731902050505070

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBI52020-02-14
GAT42020-03-30
HWC22025-08-15

PMN#

GUDID#

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