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

Pin, Fixation, Resorbable, Hard Tissue

21 CFR 888.3040 / Orthopedic
FDA source (opens on fda.gov)

OVZ is the FDA product code for Pin, Fixation, Resorbable, Hard Tissue, a class II device type, regulated under 21 CFR 888.3040. FDA's definition for this code reads: "Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OVZ
Device name
Pin, Fixation, Resorbable, Hard Tissue
FDA definition
Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.
Regulation
21 CFR 888.3040
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 OVZ

By decision year
3 clearances under product code OVZ with a decision year between 1990 and 2014, 1990 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OVZ by decision year
YearClearances
19901
20111
20141

Applicants with the most clearances

Product code OVZ
Applicants holding the most 510(k) clearances under product code OVZ
ApplicantClearances
Zimmer GmbH1
Depuy Orthopaedics Inc.1
Johnson & Johnson International1

Companies listing this code with FDA

Companies whose registered establishments list this code