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

Prosthesis, Wrist, Hemi-, Ulnar

21 CFR 888.3810 / Orthopedic
FDA source (opens on fda.gov)

KXE is the FDA product code for Prosthesis, Wrist, Hemi-, Ulnar, a class II device type, regulated under 21 CFR 888.3810. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
KXE
Device name
Prosthesis, Wrist, Hemi-, Ulnar
Regulation
21 CFR 888.3810
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
16
Ingested recalls
3

Clearances, product code KXE

By decision year
16 clearances under product code KXE with a decision year between 1979 and 2019, 2005 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KXE by decision year
YearClearances
19791
19811
19981
20011
20021
20042
20053
20061
20082
20121
20151
20191

Applicants with the most clearances

Product code KXE
Applicants holding the most 510(k) clearances under product code KXE
ApplicantClearances
Aptis Medical, LLC.5
Avanta Orthopaedics, Inc.2
Ascension Orthopedic1
Ascension Orthopedics, Inc.1
Cutter Laboratories, Inc.1
Dow Corning Corp. Healthcare Industries Materials1
Kapp Surgical GmbH1
Remi Sciences, Inc.1
Small Bone Innovations, Inc.1
Stuckenbrock Medizintechnik GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order