FDA Product Code OSF: Patient Specific Manual Orthopedic Stereotaxic System
Intended For Defining Orthopedic Acetabular Implant Alignment Relative To A Patient's Anatomy.
Leading manufacturers include Surgical Planning Associates, Inc..
FDA 510(k) Cleared Patient Specific Manual Orthopedic Stereotaxic System Devices (Product Code OSF)
About Product Code OSF - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code OSF since 2010, with 3 receiving FDA clearance (average review time: 351 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OSF have taken an average of 314 days to reach a decision - down from 370 days historically, suggesting improved FDA processing for this classification.
OSF devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →