DeGen Medical Receives E3 MIS™ System FDA Clearance

Florence, S.C., March 09, 2018 (GLOBE NEWSWIRE) — DeGen Medical announced the FDA clearance of E3 MIS™ Modular Pedicle Screw System for thoraco-lumbar spine. E3 MIS™system addresses a wide range of surgical options, pre-assembled or modular screws, straight or curved rods, and titanium or cobalt-chrome rods. It allows the surgeon intra-operative flexibility for bone grafting and screw placement. The screw thread is specifically engineered to combine the option for standard or cortical screw placement.
E3 MIS™ System allows surgeons three different MIS towers to choose from inter-operatively in a two-tray configuration.
The E3 MIS™ System features:
- Modular tulip heads and screws compatible with the current F1 MPS™ system and 5.5mm rod offerings.
- Several titanium alloy and cobalt-chrome modular screw head options, including MIS and Spondy.
- A complement of surgical instruments to facilitate MIS and Open approaches.
- Screw sizes starting at 4.0mm diameter (solid) and 4.5mm diameter (cannulated) through 10mm diameter.
- Cortical-cancellous thread design or F1 MPS™ thread design.
- Four different options for percutaneous rod insertion.
- MIS towers range from 11mm to 16mm in diameter.
DeGen Medical would like to thank the following doctors for their contributions to this innovative and versatile system: Dr. Rakesh Chokshi, Dr. P. Douglas deHoll, Dr. Gene Massey, and Dr. Daniel Williams.
About DeGen Medical, Inc.
DeGen Medical, Inc. is a medical-device development company dedicated to providing surgeons with innovative products engineered to improve quality of life for patients with complex spinal disorders. World-class implants, coupled with intuitively-designed instrumentation, provide a complete package to promote superior surgical outcomes. Our passion to advance spine-care solutions is driven by clinical insights, sound research, and science-based design. DeGen Medical maintains the highest quality standards to provide reliable products and safeguard patient health.
For more information, please contact:
Jessica McCracken DeGen Medical, Inc. 843-407-0538 jessica@degenmedical.com
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