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)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

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.

1 summaries are archived here for direct download.