NovoSource is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
1
Total
1
Cleared
0
Denied
NovoSource, is an orthopedic implant and instrument manufacturer focused exclusively on total joint replacements. The company operates with a manufacturing facility in Morgantown, West Virginia, and emphasizes proven product designs, unrivaled quality, and responsible pricing for surgeons and patients.
NovoSource has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory activity is concentrated in orthopedic devices, with its latest clearance in 2026, demonstrating active market engagement.
The company's product portfolio includes knee and hip replacement systems built on clinically successful implant designs. NovoSource emphasizes anatomically-based geometries, streamlined instrumentation, and optimized bearing surfaces to maximize surgeon satisfaction and patient outcomes. The NovoKnee System represents the company's core knee offering, featuring interchangeable implants, refined posterior stabilized designs, and intuitive surgical instruments.
Explore NovoSource's cleared device names, product codes, and clearance dates in the database.
FDA 510(k) Regulatory Record - NovoSource
1 devices