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

Appliance, Nail/Blade/Plate Combination, Single Component

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

KWK is the FDA product code for Appliance, Nail/Blade/Plate Combination, Single Component, a class II device type, regulated under 21 CFR 888.3030. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
KWK
Device name
Appliance, Nail/Blade/Plate Combination, Single Component
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
1
Ingested recalls
0

Clearances, product code KWK

By decision year
1 clearance under product code KWK with a decision year between 1994 and 1994, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KWK by decision year
YearClearances
19941

Applicants with the most clearances

Product code KWK
Applicants holding the most 510(k) clearances under product code KWK
ApplicantClearances
Onyx Medical LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code KWK.