LZN · Class II · 21 CFR 878.3300

FDA Product Code LZN: Cement Obturator

Leading manufacturers include Howmedica Corp., Sunmed, Inc. and Allo Pro Corp..

37
Total
37
Cleared
121d
Avg days
1977
Since
37 devices
25–37 of 37
Cleared Feb 08, 1993
RESORABPLUG
K920118
Sofamor Danek Mfg., Inc.
Orthopedic · 392d
Cleared Nov 04, 1992
CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL
K923909
Orthomet, Inc.
Orthopedic · 92d
Cleared Sep 04, 1991
ADG INTRAMEDULLARY BONE PLUG - VENTED
K911717
American Design Group, Inc.
Orthopedic · 140d
Cleared Mar 05, 1991
THE UNIVERSAL CEMENT PLUG(TM)
K910135
Biotron , Ltd.
Orthopedic · 55d
Cleared Sep 11, 1990
ADG BONE PLUG
K902615
American Design Group, Inc.
Orthopedic · 90d
Cleared Mar 01, 1990
CENTERING PLUG
K900392
Allo Pro Corp.
Orthopedic · 34d
Cleared Feb 03, 1989
HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG
K890326
Howmedica Corp.
Orthopedic · 11d
Cleared Sep 24, 1985
SILASTIC INFLATABLE BONE PLUG H.P.
K853186
Dow Corning Corp. Healthcare Industries Materials
Orthopedic · 56d
Cleared Aug 12, 1985
HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER
K852449
Howmedica Corp.
Orthopedic · 63d
Cleared Apr 12, 1983
POLYETHYLENE MEDULLARY PLUG - STIIHMER/
K830949
Allo Pro Corp.
Orthopedic · 19d
Cleared Feb 23, 1981
HARRIS CEMENT RESTRICTOR
K810353
Cintor Orthopaedic Div.
Orthopedic · 13d
Cleared Jun 27, 1979
PLUG-LOK CEMENT RESTIRCTOR
K791125
Richard'S Medical Equip., Inc.
Orthopedic · 9d
Cleared Aug 04, 1977
WROUGHT (FORGED) VITALLIUM
K771408
Howmedica Corp.
Orthopedic · 6d