OSF

Patient Specific Manual Orthopedic Stereotaxic System

Product code
OSF
Device name
Patient Specific Manual Orthopedic Stereotaxic System
Device class
Class 2
21 CFR
21 CFR 882.4560
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
3

FDA classification definition

Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-08-08.

NumberDecision dateApplicantDevice name
K2333152024-08-08Surgical Planning Associates, Inc.HipXpert and HipInsight System summary
Official FDA classification page: OSF
Classification and pathway per current FDA publications. Data from openFDA (CC0).