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

Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained

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

JWI is the FDA product code for Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained, a class II device type, regulated under 21 CFR 888.3800. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JWI
Device name
Prosthesis, Wrist, 2 Part Metal-Plastic 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
3
Ingested recalls
0

Clearances, product code JWI

By decision year
3 clearances under product code JWI with a decision year between 1980 and 1995, 1995 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JWI by decision year
YearClearances
19801
19952

Applicants with the most clearances

Product code JWI
Applicants holding the most 510(k) clearances under product code JWI
ApplicantClearances
Ferguson Medical1
Meridian Diagnostics, Inc.1
Turnkey Intergration USA, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code