MBL

Product Code: MBL

Products Classified as MBL

4618

Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous

Hip Joint Metal/polymer/metal Semi-constrained Porous-coated Uncemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4618

Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous

Hip Joint Metal/polymer/metal Semi-constrained Porous-coated Uncemented Prosthesis.

FDA Consensus Standards

• Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous [34059]: 21 CFR §888.3358 🔎
• Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous [38231]: 21 CFR §888.3358 🔎
• Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous [37410]: 21 CFR §888.3358 🔎
• Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous [37411]: 21 CFR §888.3358 🔎
• Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous [35610]: 21 CFR §888.3358 🔎
• Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous [33508]: 21 CFR §888.3358 🔎
• Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous [32210]: 21 CFR §888.3358 🔎
• Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous [38290]: 21 CFR §888.3358 🔎
• Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous [32380]: 21 CFR §888.3358 🔎
• Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous [33509]: 21 CFR §888.3358 🔎
• Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous [33949]: 21 CFR §888.3358 🔎
• Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous [32381]: 21 CFR §888.3358 🔎

Pre-market Notifications for MBL

K182535	R3 Anteverted Liners	Smith & Nephew, Inc.
K161233	OXINIUM DH Fermoral Heads	SMITH & NEPHEW, INC.
K122382	DYNASTY BIOFOAM SHELL	WRIGHT MEDICAL TECHNOLOGY, INC.
K113848	R3 XLPE LINERS	SMITH & NEPHEW, INC.
K102370	R3 XLPE ANTEVERTED LINERS	SMITH & NEPHEW, INC.
K093363	COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS	SMITH & NEPHEW, INC.
K092386	R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS	SMITH & NEPHEW, INC.
K070756	SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM	SMITH & NEPHEW, INC.
K061253	REFLECTION 3 ACETABULAR SYSTEM	SMITH & NEPHEW, INC.
K960094	REFLECTION DUAL DIMENSION SHELL	SMITH & NEPHEW RICHARDS, INC.
K931107	LOGYK ACETABULAR COMPONENT SYSTEM	ARTHRONICS, INC.

Global Unique Device Identification Database

• 00814703015014: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
• 00814703014970: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
• 00814703014956: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
• 00814703014925: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
• 00814703014918: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
• 00814703014895: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
• 00814703012877: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
• 00814703012860: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
• 00814703012815: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
• 00814703012778: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
• 00814703012761: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
• 00814703012532: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
• 00814703012501: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
• 00814703012464: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
• 00814703012457: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Maude Adverse Events

R3 20 DEG XLPE ACET LNR 36MM X 54MM	SMITH & NEPHEW, INC.	2020-03-26
RF FSO CER ACET COMP 56MM	SMITH & NEPHEW, INC.	2020-03-19
R3 MULTI HOLE ACETABULAR SHELL 50MM	SMITH & NEPHEW, INC.	2020-03-13
R3 0 HOLE HA CTD ACET SHELL 50MM	SMITH & NEPHEW, INC.	2020-03-11
R3 0 HOLE HA CTD ACET SHELL 50MM	SMITH & NEPHEW, INC.	2020-03-11
R3 0 HOLE HA CTD ACET SHELL 52MM	SMITH & NEPHEW, INC.	2020-03-11
R3 MULTI HOLE ACETABULAR SHELL 54MM	SMITH & NEPHEW, INC.	2020-03-11
R3 MULTI HOLE ACETABULAR SHELL 54MM	SMITH & NEPHEW, INC.	2020-03-11
R3 3 HOLE ACET SHELL MM46	SMITH & NEPHEW, INC.	2020-02-18
R3 MULTI HOLE ACETABULAR SHELL 48MM	SMITH & NEPHEW, INC.	2020-02-18
R3 20 DEG XLPE ACET LNR 32MM X 48MM	SMITH & NEPHEW, INC.	2020-02-18
R3 0 DEG XLPE ACET LNR 36MM X 54MM	SMITH & NEPHEW, INC.	2020-02-14
R3 20 DEG +4 XLPE ACET LNR 36MM X 54MM	SMITH & NEPHEW, INC.	2020-02-14
R3 0 HOLE ACET SHELL 56MM	SMITH & NEPHEW, INC.	2020-02-12
R3 20 DEG XLPE ACET LNR 28MM X 48MM	SMITH & NEPHEW, INC.	2020-02-05
R3 0 DEG XLPE ACET LNR 36MM X 54MM	SMITH & NEPHEW, INC.	2020-02-04
R3 3 HOLE ACET SHELL MM46	SMITH & NEPHEW, INC.	2020-02-03
R3 0 DEG XLPE ACET LNR 40MM X 64MM	SMITH & NEPHEW, INC.	2020-01-31
40MM OXINIUM MODULAR HEAD	SMITH & NEPHEW, INC.	2020-01-31
R3 20 DEG XLPE LNR 40MM ID X 58OD	SMITH & NEPHEW, INC.	2020-01-31
R3 20 DEG +4 XLPE ACET LNR 36MM X 54MM	SMITH & NEPHEW, INC.	2020-01-27
R3 3 HOLE ACET SHELL 54MM	SMITH & NEPHEW, INC.	2020-01-27
R3 20 DEG XLPE ACET LNR 36MM X 60MM	SMITH & NEPHEW, INC.	2020-01-21
R3 0 DEG XLPE ACET LNR 36MM X MM56	SMITH & NEPHEW, INC.	2020-01-17
R3 20 DEG XLPE ACET LNR 32MM X 52MM	SMITH & NEPHEW, INC.	2020-01-17
REDAPT MODULAR SHELL 60MM	SMITH & NEPHEW, INC.	2020-01-16
R3 20 DEG XLPE ACET LNR 36MM X 52MM	SMITH & NEPHEW, INC.	2020-01-14
R3 MULTI HOLE ACETABULAR SHELL 56MM	SMITH & NEPHEW, INC.	2020-01-14
R3 20 DEG XLPE ACET LNR 28MM X 46MM	SMITH & NEPHEW, INC.	2020-01-14
R3 0 HOLE ACET SHELL 52MM	SMITH & NEPHEW, INC.	2020-01-09
R3 0 DEGREE XLPE ACET LNR 40MM ID X 60OD	SMITH & NEPHEW, INC.	2020-01-07
R3 3 HOLE ACET SHELL 50MM	SMITH & NEPHEW, INC.	2020-01-07
R3 0 DEG +4 XLPE ACET LNR 40MM X 58 OD	SMITH & NEPHEW, INC.	2019-12-27
REF THREE HOLE SHELL 50MM	SMITH & NEPHEW, INC.	2019-12-24
R3 0 DEG XLPE ACET LNR 36MM X MM56	SMITH & NEPHEW, INC.	2019-12-23
R3 3 HOLE ACET SHELL 52MM	SMITH & NEPHEW, INC.	2019-12-11
R3 20 DEG XLPE ACET LNR 36MM X 52MM	SMITH & NEPHEW, INC.	2019-12-11
R3 0 DEG XLPE ACET LNR 36MM X 52MM	SMITH & NEPHEW, INC.	2019-12-04
R3 3 HOLE ACET SHELL 52MM	SMITH & NEPHEW, INC.	2019-12-04
R3 0 HOLE ACET SHELL 52MM	SMITH & NEPHEW, INC.	2019-12-04
R3 0 DEG XLPE ACET LNR 32MM X 48MM	SMITH & NEPHEW, INC.	2019-11-26
R3 3 HOLE ACET SHELL MM48	SMITH & NEPHEW, INC.	2019-11-26
R3 20 DEG XLPE ACET LNR 32MM X 50MM	SMITH & NEPHEW, INC.	2019-11-25
REF THREE HOLE SHELL 56MM	SMITH & NEPHEW, INC.	2019-11-22
R3 20 DEG XLPE LNR 40MM ID X 64OD	SMITH & NEPHEW, INC.	2019-11-21
TITANIUM MODULAR HEAD SLEEVE 4MM X SHORT	SMITH & NEPHEW, INC.	2019-11-21
REF THREE HOLE SHELL 54MM	SMITH & NEPHEW, INC.	2019-11-20
REF INTERFIT THRD HOLE COVER	SMITH & NEPHEW, INC.	2019-11-20
REF NO HOLE SHELL SZ 54MM	SMITH & NEPHEW, INC.	2019-11-20
NONRIM SPEED PIN 65 STERILE	SMITH & NEPHEW, INC.	2019-11-19