LZY · Class II · 21 CFR 888.3360

FDA Product Code LZY: Prosthesis, Hip, Hemi-, Femoral, Metal Ball

Leading manufacturers include Medacta International, Smith & Nephew, Inc. and Protek, Inc..

8
Total
8
Cleared
145d
Avg days
1989
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Prosthesis, Hip, Hemi-, Femoral, Metal Ball Devices (Product Code LZY)

8 devices
1–8 of 8
Cleared Jul 19, 2023
TANDEM Hip System
K231448
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Aug 16, 2011
ENDO HEAD
K111145
Medacta International
Orthopedic · 116d
Cleared Jan 05, 1998
PRE-POWDERED NITRILE EXAMINATION GLOVES
K974442
P.T. Latexindo Tobaperkasa
Orthopedic · 41d
Cleared Mar 10, 1992
IONGUARD TITANIUM MODULAR HEADS
K915548
Biomet, Inc.
Orthopedic · 90d
Cleared Oct 03, 1990
MODULAR CATHCART FRACTURE SYSTEM
K903084
Depuy, Inc.
Orthopedic · 83d
Cleared Feb 15, 1990
UNI-POLAR HEAD
K896580
Richards Medical Co., Inc.
Orthopedic · 90d
Cleared Jul 19, 1989
FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR
K892059
Protek, Inc.
Orthopedic · 112d

About Product Code LZY - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code LZY since 1989, with 8 receiving FDA clearance (average review time: 145 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.