510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OSFClass II

Patient Specific Manual Orthopedic Stereotaxic System

21 CFR 882.4560 / Neurology
FDA source (opens on fda.gov)

OSF is the FDA product code for Patient Specific Manual Orthopedic Stereotaxic System, a class II device type, regulated under 21 CFR 882.4560. FDA's definition for this code reads: "Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OSF
Device name
Patient Specific Manual Orthopedic Stereotaxic System
FDA definition
Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
1

Clearances, product code OSF

By decision year
3 clearances under product code OSF with a decision year between 2010 and 2024, 2010 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OSF by decision year
YearClearances
20101
20211
20241

Applicants with the most clearances

Product code OSF
Applicants holding the most 510(k) clearances under product code OSF
ApplicantClearances
Surgical Planning Associates3

Companies listing this code with FDA

Companies whose registered establishments list this code