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

Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

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

JWJ is the FDA product code for Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained, a class II device type, regulated under 21 CFR 888.3800. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JWJ
Device name
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, 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
17
Ingested recalls
0

Clearances, product code JWJ

By decision year
17 clearances under product code JWJ with a decision year between 1980 and 2024, 2024 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JWJ by decision year
YearClearances
19802
19941
19961
19981
20022
20032
20041
20081
20141
20202
20243

Applicants with the most clearances

Product code JWJ
Applicants holding the most 510(k) clearances under product code JWJ
ApplicantClearances
Kinetikos Medical, Inc.3
Zimmer GmbH2
Skeletal Dynamics, Inc2
Arthrosurface, Inc.1
Ascension Orthopedics, Inc.1
Avanta Orthopaedics, Inc.1
Biomet Manufacturing Corp1
Depuy Orthopaedics Inc.1
Extremity Medical, LLC1
Integra LifeSciences Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order