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..
3
Total
3
Cleared
351d
Avg days
2010
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Patient Specific Manual Orthopedic Stereotaxic System Devices (Product Code OSF)
3 devices
Cleared
Aug 08, 2024
HipXpert and HipInsight System
Surgical Planning Associates, Inc.
Orthopedic
314d
Cleared
Jan 28, 2021
HipXpert 3D Display and Anchoring Application
Surgical Planning Associates, Inc.
Orthopedic
345d
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 declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.