510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
KWNClass II

Prosthesis, Wrist, Carpal Lunate

21 CFR 888.3750 / Orthopedic
FDA source (opens on fda.gov)

KWN is the FDA product code for Prosthesis, Wrist, Carpal Lunate, a class II device type, regulated under 21 CFR 888.3750. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KWN
Device name
Prosthesis, Wrist, Carpal Lunate
Regulation
21 CFR 888.3750
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
5
Ingested recalls
0

Clearances, product code KWN

By decision year
5 clearances under product code KWN with a decision year between 1979 and 2014, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KWN by decision year
YearClearances
19791
19871
20051
20081
20141

Applicants with the most clearances

Product code KWN
Applicants holding the most 510(k) clearances under product code KWN
ApplicantClearances
Arthrosurface, Inc.1
Ascension Orthopedics, Inc.1
Biomet Manufacturing Corp1
Dow Corning Wright1
Howmedica Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code