Spine Innovation LLC, a US-based medical device startup that develops novel interbody fusion implants, announced on Monday that it has received FDA 510(k) approval to market the LOGIC Titanium Implant System.
The LOGIC Implant System is the next generation LOGIC implant incorporating OsteoSync Ti, a patented, pure titanium lattice material from Sites Medical which has been implanted in more than 250,000 patients since 2014.
According to Spine Innovation, the patented LOGIC implant is designed with a reduced profile during implantation that more than doubles in size during expansion for maximum stability and bone graft volume. Manufactured from polyether ether ketone (PEEK), the design has been used successfully in the United States for 10 years.
The implant restores disc height and sagittal balance while resisting subsidence and expulsion due to an 18 mm x 26 mm expanded footprint spanning the vertebral body and is now available in OsteoSync Ti.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval