Device classification

Patient Specific Manual Orthopedic Stereotaxic System

Neurology · 21 CFR 882.4560

Class IIProduct code OSF
Open FDA's page for this record
Third party flag
N
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
OSF
Review panel
OR
Medical specialty
NE
Device name
Patient Specific Manual Orthopedic Stereotaxic System
Medical specialty description
Neurology
Device class
2
Definition
Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.
Regulation number
882.4560
Implant flag
N
Submission type ID
1
Harmonized identifiers (openFDA)
K number
K093491, K233315, K200384
Registration number
3016676864, 3008869747
FEI number
3016676864, 3008869747
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.