LZV · Class II · 21 CFR 888.4580

FDA Product Code LZV: System, Cement Removal Extraction

Leading manufacturers include Origin Medsystems, Inc., Orthosonics, Ltd. and Albert K. Chin.

7
Total
7
Cleared
112d
Avg days
1989
Since

FDA 510(k) Cleared System, Cement Removal Extraction Devices (Product Code LZV)

7 devices
1–7 of 7
Cleared Jun 06, 2002
OSCAR, MODEL OE3000
K021502
Orthosonics, Ltd.
Orthopedic · 28d
Cleared Jul 15, 1996
STRYKER CEMENT REMOVAL SYSTEM
K961101
Stryker Corp.
Orthopedic · 118d
Cleared Jan 21, 1994
ACRYL-X II SYSTEM
K930629
Sonokinetics, Inc.
Orthopedic · 347d
Cleared Nov 27, 1990
ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS
K904156
Origin Medsystems, Inc.
Orthopedic · 81d
Cleared Nov 20, 1990
PROSTHETIC CEMENT REMOVER
K904180
Origin Medsystems, Inc.
Orthopedic · 70d
Cleared May 02, 1989
IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR
K891472
Implant Technology, Inc.
Orthopedic · 48d
Cleared Apr 19, 1989
PROSTHETIC CEMENT REMOVER
K890285
Albert K. Chin
Orthopedic · 90d

About Product Code LZV - Regulatory Context