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

Ankle Arthroplasty Implantation System

21 CFR 888.3110 / Orthopedic
FDA source (opens on fda.gov)

OYK is the FDA product code for Ankle Arthroplasty Implantation System, a class II device type, regulated under 21 CFR 888.3110. FDA's definition for this code reads: "Intended to be used to assist in the implantation of a specific ankle arthroplasty device. Indicated to include guiding alignment, making or establishing cuts, and sizing". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OYK
Device name
Ankle Arthroplasty Implantation System
FDA definition
Intended to be used to assist in the implantation of a specific ankle arthroplasty device. Indicated to include guiding alignment, making or establishing cuts, and sizing.
Regulation
21 CFR 888.3110
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
2

Clearances, product code OYK

By decision year
7 clearances under product code OYK with a decision year between 2020 and 2024, 2024 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code OYK by decision year
YearClearances
20201
20232
20244

Applicants with the most clearances

Product code OYK
Applicants holding the most 510(k) clearances under product code OYK
ApplicantClearances
3D Systems, Inc.6
restor3d, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code