OSFClass II

Patient Specific Manual Orthopedic Stereotaxic System

Neurology · 21 CFR 882.4560

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

MDR events0All time

Recalls1All time

Registered firms6Currently listed

510(k) clearances3All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Materialise N.V.
TerminatedOct 23, 2015
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
Z-0162-2016 · View FDA record ↗

Registered firms

6 firms currently registered for this product code

510(k) clearances

3 clearances for this product code