DeviceClearance

Product code OSF— Neurology

HIP SEXTANT INSTRUMENT SYSTEM

Classification name
Patient Specific Manual Orthopedic Stereotaxic System
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Total cleared
3
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code OSF under 21 CFR 882.4560, via openFDA

Market context for product code OSF

FDA has cleared 3 devices under product code OSF between 2010 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OSF

Recent clearances under product code OSF

Data sourced from openFDA. This site is unofficial and independent of the FDA.