K852137Substantially Equivalent

Fenlin Total Shoulder

Name: K852137 Fenlin Total Shoulder
Creator: Zimmer, Inc.
Published: 1986-02-12
License: https://open.fda.gov/license/

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent

FDA source

K852137 is the FDA 510(k) clearance record for FENLIN TOTAL SHOULDER, cleared for Zimmer, Inc. on 1986-02-12. FDA records list 872 510(k) clearances for Zimmer, Inc., from 1976-07-26 to 2026-07-01. As of 2026-09-10, FDA records show no recalls naming K852137.

Clearance record

Decision date: 1986-02-12
Received: 1985-05-16 (272 days to decision)
Review panel: Unknown
Applicant: Zimmer, Inc. P.O. Box 708, Warsaw IN
Third party review: No