LZN · Class II · 21 CFR 878.3300

FDA Product Code LZN: Cement Obturator

Leading manufacturers include Howmedica Corp., Johnson & Johnson Professionals, Inc. and Smith & Nephew, 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 Nov 19, 2002
BIOBUCK CEMENT RESTRICTOR
K023680
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Aug 13, 1999
OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
K992462
Howmedica Osteonics Corp.
Orthopedic · 21d
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 Sep 20, 1994
P.F.C. CEMENT RESTRICTOR
K942060
Johnson & Johnson Professionals, Inc.
Orthopedic · 144d
Cleared Feb 03, 1989
HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG
K890326
Howmedica Corp.
Orthopedic · 11d
Cleared Aug 12, 1985
HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER
K852449
Howmedica Corp.
Orthopedic · 63d
Cleared Aug 04, 1977
WROUGHT (FORGED) VITALLIUM
K771408
Howmedica Corp.
Orthopedic · 6d

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.