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

Prosthesis, Wrist, Semi-Constrained

21 CFR 888.3800 / Orthopedic
FDA source (opens on fda.gov)

KWM is the FDA product code for Prosthesis, Wrist, Semi-Constrained, a class II device type, regulated under 21 CFR 888.3800. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KWM
Device name
Prosthesis, Wrist, Semi-Constrained
Regulation
21 CFR 888.3800
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
6
Ingested recalls
0

Clearances, product code KWM

By decision year
6 clearances under product code KWM with a decision year between 1979 and 1988, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KWM by decision year
YearClearances
19791
19802
19821
19871
19881

Applicants with the most clearances

Product code KWM
Applicants holding the most 510(k) clearances under product code KWM
ApplicantClearances
Depuy, Inc.2
Zimmer GmbH1
Dow Corning Wright1
Laure Prosthetics, Inc.1
Protek, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code