Product code JWI— Orthopedic

ASPERGILLUS SP., ANTIGEN

Classification name: Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
Device class: Class 2
Regulation: 21 CFR 888.3800
Advisory panel: Orthopedic
Total cleared: 3
First cleared: 1980-01-17
Most recent: 1995-05-22

Market context for product code JWI

FDA has cleared 3 devices under product code JWI between 1980 and 1995, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

19952 clearances
19801 clearance

Top applicants under product code JWI

Turnkey Intergration USA, Inc.1 clearance
Meridian Diagnostics, Inc.1 clearance
Ferguson Medical1 clearance

Recent clearances under product code JWI

K931265 — FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2NDFerguson Medical·1995-05-22
K940297 — UNIVERSAL WRISTTurnkey Intergration USA, Inc.·1995-02-06
K792687 — ASPERGILLUS SP., ANTIGENMeridian Diagnostics, Inc.·1980-01-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.