Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011061237

FEI Number

3011061237

Entity Name

Dunamis Medical LLC

City/State/Country

Greenville, AL, US

Establishment Address

104 Camellia Ave, Suite B, Greenville, AL 36037, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Dunamis Medical LLC (Owner Number: 10047203)

Owner / Operator Contact Address

104 Camellia Ave, Suite B, Greenville, AL 36037, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FlipTight Loop Fiber-Connect Force DFX Suture Force DFX Suture-Xtreme Force DFX Suture Loop-Xtreme Dunamis Drill Bit Cannulated Drill Bits Reamers Solid Drill Bits Suture Anchor PEEK PUNCHTAC INSTRUMENT TRAY TIGHTFIX INSTRUMENT TRAY ACL-PCL INSTRUMENT TRAY Orca Flipper Trays Fastloop Green Fastloop White Dunamis Pick Dunamis Interference Screw Insertion Tool Dunamis Positioning Tool Orca Flipper 1mm Bushing for CMC Guide 1mm Bushing for Hallux Guide 1.4mm Bushing for CMC Guide Hallux Guide 1.4mm Bushing for Hallux Guide CMC Guide Tensioners Dunamis Tap Calibrated Probe 2.4mm Slotted Passing Pin Shuttle Wire Guide Pin Suture Passer Transporter Nitinol Passer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-12-27
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-04-23
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2015-07-29
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2014-07-18
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-09-11
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-04-26
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-12-21
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2014-07-18
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2014-07-18
HXB	Probe	Orthopedic	Class 1	888.4540	2017-02-20
HWQ	Passer	Orthopedic	Class 1	888.4540	2017-02-20

Official Correspondent

Prithviraj Chavan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Dunamis Medical LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011061237. Last updated year: 2026. Please use registration number 3011061237 when referencing this establishment in official correspondence.