LZN · Class II · 21 CFR 878.3300

FDA Product Code LZN: Cement Obturator

Leading manufacturers include Howmedica Corp., Johnson & Johnson Professionals, Inc. and Sunmed, Inc..

37
Total
37
Cleared
121d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Cement Obturator Devices (Product Code LZN)

37 devices
1–24 of 37
Cleared May 20, 2022
Artisan Bone Plug, Universal Cement Restrictor
K220838
Howmedica Osteonics, Dba Stryker Orthopaedics
Orthopedic · 59d
Cleared Sep 14, 2006
TORNIER CEMENT RESTRICTOR
K061824
Tornier
Orthopedic · 78d
Cleared Nov 26, 2003
CEMSTOP CEMENT RESTRICTOR
K032685
Teknimed, S.A.
Orthopedic · 89d
Cleared Nov 19, 2002
BIOBUCK CEMENT RESTRICTOR
K023680
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Sep 19, 2001
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
K011943
Kensey Nash Corp.
Orthopedic · 90d
Cleared Apr 20, 2001
SYNPLUG
K010840
Isotis NV
Orthopedic · 30d
Cleared May 04, 2000
SHUTTLE STOP
K000587
Isotis NV
Orthopedic · 72d
Cleared May 04, 2000
CEMSTOP CEMENT RESTRICTOR
K993841
Encore Orthopedics, Inc.
Orthopedic · 174d
Cleared Aug 13, 1999
OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
K992462
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Aug 29, 1997
LINK CEMENT PLUG
K972411
Turnkey Intergration USA, Inc.
Orthopedic · 64d
Cleared May 09, 1997
OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
K970779
Osteonics Corp.
Orthopedic · 66d
Cleared Feb 27, 1996
ORTHOPLUG HARD BONE DESIGN
K955631
Sunmed, Inc.
Orthopedic · 78d
Cleared Feb 27, 1996
ORTHOPLUG SOFT BONE DESIGN
K955632
Sunmed, Inc.
Orthopedic · 78d
Cleared Jan 26, 1996
PRIME FEMORAL CEMENT PLUG
K955751
Orthopaedic Innovations, Inc.
Orthopedic · 37d
Cleared Jul 11, 1995
CEMENTRALIZER DISTAL STEM CENTRALIZER
K951930
Depuy, Inc.
Orthopedic · 97d
Cleared May 16, 1995
EXETER INTRAMEDULLARY BONE PLUG
K933077
Howmedica Corp.
Orthopedic · 692d
Cleared May 16, 1995
HOWMEDICE BONE PLUG
K951860
Howmedica Corp.
Orthopedic · 25d
Cleared May 16, 1995
PFC CEMENT RESTRICTOR
K951934
Johnson & Johnson Professionals, Inc.
Orthopedic · 21d
Cleared May 11, 1995
BIOSTOP G BONE CEMENT RESTRICTOR
K943727
Landos, Inc.
Orthopedic · 282d
Cleared Sep 23, 1994
IMPLEX CEMENT RESTRICTOR SYSTEM
K943378
Implex Corp.
Orthopedic · 72d
Cleared Sep 20, 1994
ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR
K932595
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 480d
Cleared Sep 20, 1994
P.F.C. CEMENT RESTRICTOR
K942060
Johnson & Johnson Professionals, Inc.
Orthopedic · 144d
Cleared Jun 28, 1994
BIO-PREP CEMENT RESTRICTOR
K931847
Biomedical Devices, Inc.
Orthopedic · 441d
Cleared Jan 27, 1994
UNIVERSAL BONE CEMENT KIT
K931540
Biodynamic Technologies, Inc.
Orthopedic · 304d

About Product Code LZN - Regulatory Context

510(k) Submission Activity

37 total 510(k) submissions under product code LZN since 1977, with 37 receiving FDA clearance (average review time: 121 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.