Data / Medical devices / United States / Dunamis Medical LLC
Dunamis Medical LLC: FDA-registered device maker in Greenville, AL, United States, 10 510(k) clearances
Dunamis Medical LLC is registered with the FDA (registration 3011061237) in Greenville, AL, United States. It lists 13 device types. The FDA files 10 510(k) clearances under its listings, the newest dated August 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011061237
- Address
- 104 Camellia Ave Suite B, Greenville, AL, United States, 36037
- Owner or operator
- Dunamis Medical LLC (10047203)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 18, 2014
- Registered through
- 2026
- Brand names listed
- 1.4mm Bushing for CMC Guide, 1.4mm Bushing for Hallux Guide, 1mm Bushing for CMC Guide, 1mm Bushing for Hallux Guide, 2.4mm Slotted Passing Pin, 3mm / 3.5mm Starter Punch, ACL-PCL INSTRUMENT TRAY, CMC Guide and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Passer | HWQ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Punch, Femoral Neck | HWP | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Starter, Bone Screw | HWD | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 15, 2025 | K250867 | Dunamis Screw and Suture Locking System | HWC | Substantially Equivalent | Dunamis Medical, LLC | accessdata.fda.gov |
| March 30, 2020 | K192490 | Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch | GAT | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| February 14, 2020 | K193245 | Dunamis PunchTac Suture Anchors | MBI | Substantially Equivalent | Dunamis, LLC | accessdata.fda.gov |
| August 29, 2019 | K191319 | Dunamis Fixation Button System | MBI | Substantially Equivalent | Dunamis, LLC | accessdata.fda.gov |
| October 3, 2017 | K172016 | Force Fiber Fusion Suture | GAT | Substantially Equivalent | Teleflex Medical Incorporated | accessdata.fda.gov |
| July 6, 2016 | K160996 | Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm | MBI | Substantially Equivalent | Dunamis, LLC | accessdata.fda.gov |
| June 3, 2016 | K160655 | OrthoButton CL | MBI | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| March 3, 2016 | K153746 | Dunamis Force DFX Tensile Tape | GAT | Substantially Equivalent | Dunamis, LLC | accessdata.fda.gov |
| October 14, 2015 | K151220 | Dunamis Interference Screw | MBI | Substantially Equivalent | Dunamis, LLC | accessdata.fda.gov |
| June 29, 2015 | K150327 | Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 | GAT | Substantially Equivalent | Dunamis, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Starter, Bone Screw
- All makers of Bit, Drill
- All makers of Washer, Bolt Nut
Updated August 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.