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

Internal Hinged Elbow Fixator

21 CFR 888.3030 / Orthopedic
FDA source (opens on fda.gov)

OZI is the FDA product code for Internal Hinged Elbow Fixator, a class II device type, regulated under 21 CFR 888.3030. FDA's definition for this code reads: "The hinged internal fixator is intended to treat joint dislocations, more specifically of the elbow joint. The device is intended to be removed once stability is achieved". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OZI
Device name
Internal Hinged Elbow Fixator
FDA definition
The hinged internal fixator is intended to treat joint dislocations, more specifically of the elbow joint. The device is intended to be removed once stability is achieved.
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code OZI

By decision year
3 clearances under product code OZI with a decision year between 2015 and 2023, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OZI by decision year
YearClearances
20151
20232

Applicants with the most clearances

Product code OZI
Applicants holding the most 510(k) clearances under product code OZI
ApplicantClearances
Skeletal Dynamics, Inc3

Companies listing this code with FDA

Companies whose registered establishments list this code