# Dunamis, LLC

- Location (FDA's records): Greenville, AL
- FDA decisions: 6 (2015–2020): 6 510(k) clearances
- Product codes: MBI (4), GAT (2)
- 510(k) review time since 2016: median 85 days, against 92 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 14 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smith & Nephew Inc., Endoscopy Division: 3 (https://510kreport.com/company/smith-nephew-endoscopy-division)
- Arthrex, Inc.: 3 (https://510kreport.com/company/arthrex)
- Smith & Nephew Endoscopy, Inc.: 2 (https://510kreport.com/company/smith-nephew-endoscopy)
- Riverpoint Medical: 2 (https://510kreport.com/company/riverpoint-medical)
- Teleflex Medical: 1 (https://510kreport.com/company/teleflex-medical)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Teleflexmedical, Inc.: 1 (https://510kreport.com/company/teleflexmedical)

## Firms that cite its devices most
- Dunamis Medical, LLC: 1 (https://510kreport.com/company/dunamis-medical)

## Its most-cited devices
- K160996: Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm (2016), cited by 1
- K191319: Dunamis Fixation Button System (2019), cited by 1

## Recent decisions
- K193245: Dunamis PunchTac Suture Anchors (Feb 14, 2020)
- K191319: Dunamis Fixation Button System (Aug 29, 2019)
- K160996: Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm (Jul 6, 2016)
- K153746: Dunamis Force DFX Tensile Tape (Mar 3, 2016)
- K151220: Dunamis Interference Screw (Oct 14, 2015)
- K150327: Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 (Jun 29, 2015)

Source page: https://510kreport.com/company/dunamis