Cleared Traditional

K983141 - CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
(FDA 510(k) Clearance)

K983141 · Johnson & Johnson Professionals, Inc. · Orthopedic

Nov 1998

Decision

59d

Days

Class 2

Risk

K983141 is an FDA 510(k) clearance for the CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS, a Prosthesis, Elbow, Semi-constrained, Cemented (Class II — Special Controls, product code JDB), submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on November 6, 1998, 59 days after receiving the submission on September 8, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3160.

Submission Details

510(k) Number	K983141 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 1998
Decision Date	November 06, 1998
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF