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

Prosthesis, Hip, Femoral, Resurfacing

21 CFR 888.3400 / Orthopedic
FDA source (opens on fda.gov)

KXA is the FDA product code for Prosthesis, Hip, Femoral, Resurfacing, a class II device type, regulated under 21 CFR 888.3400. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 16 recalls.

Classification record

Product code
KXA
Device name
Prosthesis, Hip, Femoral, Resurfacing
Regulation
21 CFR 888.3400
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
23
Ingested recalls
16

Clearances, product code KXA

By decision year
23 clearances under product code KXA with a decision year between 1977 and 2021, 2002 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KXA by decision year
YearClearances
19771
19781
19791
19841
19881
19892
19911
19941
19951
19981
20001
20023
20031
20051
20061
20072
20081
20101
20211

Applicants with the most clearances

Product code KXA
Applicants holding the most 510(k) clearances under product code KXA
ApplicantClearances
Zimmer GmbH3
Biomet Orthopedics, Inc.2
Biopro, Inc.2
Corin USA2
Orthomet, Inc.2
Waldemar Link GmbH & Co. KG2
Wrightmedicaltechnologyinc2
BIOCORE9 LLC1
Depuy Orthopaedics Inc.1
Endomedics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order