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

Intraoperative Orthopedic Joint Assessment Aid

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

ONN is the FDA product code for Intraoperative Orthopedic Joint Assessment Aid, a class II device type, regulated under 21 CFR 882.4560. FDA's definition for this code reads: "Measurement and interpretation of orthopedic joint information". As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
ONN
Device name
Intraoperative Orthopedic Joint Assessment Aid
FDA definition
Measurement and interpretation of orthopedic joint information.
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
18
Ingested recalls
8

Clearances, product code ONN

By decision year
18 clearances under product code ONN with a decision year between 2007 and 2026, 2020 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code ONN by decision year
YearClearances
20071
20091
20111
20132
20141
20161
20171
20181
20203
20221
20242
20251
20262

Applicants with the most clearances

Product code ONN
Applicants holding the most 510(k) clearances under product code ONN
ApplicantClearances
Orthosensor, Inc.8
OrthAlign, Inc.3
Eventum Orthopaedics Ltd2
Synvasive Technology, Inc.2
Kamm & Associates1
These Three Medical, LLC1
Xpandortho, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code