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

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite

21 CFR 888.3500 / Orthopedic
FDA source (opens on fda.gov)

KYK is the FDA product code for Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite, a class II device type, regulated under 21 CFR 888.3500. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KYK
Device name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
Regulation
21 CFR 888.3500
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 KYK

By decision year
3 clearances under product code KYK with a decision year between 1985 and 1988, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KYK by decision year
YearClearances
19851
19871
19881

Applicants with the most clearances

Product code KYK
Applicants holding the most 510(k) clearances under product code KYK
ApplicantClearances
Depuy, Inc.2
Johnson & Johnson Professionals, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code