MBL · Class II · 21 CFR 888.3358

FDA Product Code MBL: Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous

Leading manufacturers include Smith & Nephew, Inc., Wrightmedicaltechnologyinc and Microport Orthopedics, Inc..

13
Total
13
Cleared
152d
Avg days
1994
Since

FDA 510(k) Cleared Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous Devices (Product Code MBL)

13 devices
1–13 of 13
Cleared Aug 24, 2021
Prime BIOFOAM® Multi-Hole Shells
K201157
Microport Orthopedics, Inc.
Orthopedic · 481d
Cleared Oct 06, 2020
R3 HA Coated Acetabular Shells
K201701
Smith & Nephew, Inc.
Orthopedic · 106d
Cleared Nov 19, 2018
R3 Anteverted Liners
K182535
Smith & Nephew, Inc.
Orthopedic · 66d
Cleared Dec 14, 2016
OXINIUM DH Fermoral Heads
K161233
Smith & Nephew, Inc.
Orthopedic · 226d
Cleared Oct 22, 2012
DYNASTY BIOFOAM SHELL
K122382
Wrightmedicaltechnologyinc
Orthopedic · 77d
Cleared Apr 27, 2012
R3 XLPE LINERS
K113848
Smith & Nephew, Inc.
Orthopedic · 120d
Cleared Jan 19, 2011
R3 XLPE ANTEVERTED LINERS
K102370
Smith & Nephew, Inc.
Orthopedic · 152d
Cleared Jan 26, 2010
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS
K093363
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Nov 03, 2009
R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS
K092386
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jun 06, 2007
SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
K070756
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared May 31, 2006
REFLECTION 3 ACETABULAR SYSTEM
K061253
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Mar 27, 1996
REFLECTION DUAL DIMENSION SHELL
K960094
Smith & Nephew Richards, Inc.
Orthopedic · 76d

About Product Code MBL - Regulatory Context