Cleared Traditional

K965198 - ULTIMA TPS CEMENTED STEM
(FDA 510(k) Clearance)

K965198 · Johnson & Johnson International · Orthopedic

Jul 1997

Decision

209d

Days

Class 2

Risk

K965198 is an FDA 510(k) clearance for the ULTIMA TPS CEMENTED STEM. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II — Special Controls, product code KWL).

Submitted by Johnson & Johnson International (Raynham, US). The FDA issued a Cleared decision on July 23, 1997, 209 days after receiving the submission on December 26, 1996.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number	K965198 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 1996
Decision Date	July 23, 1997
Days to Decision	209 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF