FDA Registration
Active
🇺🇸 United States
Dunamis Medical LLC
Reg #: 3011061237
·
FEI: 3011061237
·
Expires 2026
Products
13
Proprietary Names
72
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- Dunamis Medical LLC
- Registration Number
- 3011061237
- FEI Number
- 3011061237
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 104 Camellia Ave, Suite B
- City
- Greenville
- State
- AL
- ZIP
- 36037
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160655
Owner / Operator
- Firm Name
- Dunamis Medical LLC
- Operator Number
- 10047203
- Address
- 104 Camellia Ave, Suite B
- City
- Greenville
- State
- AL
- Postal Code
- 36037
- Country
- US
- Correspondent
- Prithviraj Chavan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2019-12-27 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2021-04-23 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2014-07-18 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2017-04-26 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-07-18 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2014-07-18 |
| Probe | HXB | Class 1 | Orthopedic | No | 2017-02-20 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2017-02-20 |
| Punch, Femoral Neck | HWP | Class 1 | Orthopedic | No | 2014-07-18 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2014-07-18 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2017-02-20 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2026-05-29 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2019-12-27 |
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
Dunamis Punch Tool
Dunamis Interfernce Screw Drive Shaft
TensionTac Insertion Tool
3mm / 3.5mm Starter Punch
Patella Transporter System
Dunamis Fixation Button System
Constrictor ® Rope
Constrictor® Mini
Constrictor ® Syndesmosis Repair Kit
Syndex Constrictor® Implant Kit
Constrictor® Mini Button Extender
Constrictor® Button Extender
ORCA Mini Knotless Tendon Repair
Constrictor® Mini Snare
ENOFIX with Constrictor® Technology Syndesmotic Fixation Kit
Constrictor® Link (AC)
Constrictor ® Mini Repair Kit
Constrictor ® 2 Repair Kit
Micro ORCA
Fixation Button-Oblong
ORCA Knotless Tendon Repair
Orca Xtreme Tendon Repair Kit
Micro Constrictor® Link
Orca XL Knotless Tendon Repair
Orca Xtreme Tendon Repair
Constrictor ® Mini 2 Repair Kit
Micro Constrictor ® X
Constrictor® Link
Orca Knotless Button
Micro Constrictor ®
Olecranon Transporter Repair Kit
Dunamis PunchTac Suture Anchor (PEEK)
TenoTrap (7mm x12mm Tenodesis Screw)
TensionTac 3.5 Knotless Anchor PEEK
TensionTac 3 Knotless Anchor PEEK
TenoTrap (7mm x15mm Tenodesis Screw)
Dunamis Interference Screw
Tensile Tape
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device