PBI

Product Code: PBI

Products Classified as PBI

4679

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive

Hip Joint Metal/polymer Constrained Cemented Or Uncemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4679

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive

Hip Joint Metal/polymer Constrained Cemented Or Uncemented Prosthesis.

FDA Consensus Standards

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive [34059]	21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive [38231]	21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive [34710]	21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive [33508]	21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive [32210]	21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive [32380]	21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive [33509]	21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive [32381]	21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive [34717]	21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive [38311]	21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive [38310]	21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive [33114]	21 CFR §888.3310 🔎

Pre-market Notifications for PBI

K212512	G7® Vivacit-E® Freedom® Constrained Liner	Zimmer, Inc.
K121874	G7 ACETABULAR SYSTEM	BIOMET MANUFACTURING CORP.

Global Unique Device Identification Database

00880304989115	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
00880304926912	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
00880304926844	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
00880304926820	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
00880304700307	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
00880304700260	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
00880304698406	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
00880304698291	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
00880304698246	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
00880304698000	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
00880304697805	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
00880304697775	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
00880304691582	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
00880304690981	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
00880304690905	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive

Maude Adverse Events

G7 HI-WALL E1 LINER 32MM H	ZIMMER BIOMET, INC.	2020-03-27
G7 STR MONOBLOCK SHELL INSRTR	ZIMMER BIOMET, INC.	2020-03-27
G7 10 DEG E1 LINER 36MM E	ZIMMER BIOMET, INC.	2020-03-20
G7 NEUTRAL E1 LINER	ZIMMER BIOMET, INC.	2020-03-20
G7 NEUTRAL E1 LINER	ZIMMER BIOMET, INC.	2020-03-20
G7 PPS LTD ACET SHELL 52E	ZIMMER BIOMET, INC.	2020-03-19
G7 HI-WALL E1 LINER 28MM A	ZIMMER BIOMET, INC.	2020-03-18
G7 PPS LTD ACET SHELL 52E	ZIMMER BIOMET, INC.	2020-03-13
G7 NEUTRAL E1 LINER 36MM E	ZIMMER BIOMET, INC.	2020-03-13
G7 STR MONOBLOCK SHELL INSRTR	ZIMMER BIOMET, INC.	2020-03-13
G7 NEUTRAL E1 LINER 36MM F	ZIMMER BIOMET, INC.	2020-03-12
G7 HI-WALL E1 LINER 32MM F	ZIMMER BIOMET, INC.	2020-03-03
G7 PPS LTD ACET SHELL 52E	ZIMMER BIOMET, INC.	2020-03-02
G7 10 DEG ARCOMXL LINER 36MM G	ZIMMER BIOMET, INC.	2020-02-24
G7 PPS LTD ACET SHELL 52E	ZIMMER BIOMET, INC.	2020-02-19
G7 10 DEG E1 LINER 36MM E	ZIMMER BIOMET, INC.	2020-02-19
G7 10 DEG E1 LINER 36MM F	ZIMMER BIOMET, INC.	2020-02-19
G7 PPS LTD ACET SHELL 52E	ZIMMER BIOMET, INC.	2020-02-19
G7 NEUTRAL E1 LINER 32MM E	ZIMMER BIOMET, INC.	2020-02-17
G7 HI-WALL E1 LINER 32MM E	ZIMMER BIOMET, INC.	2020-02-12
G7 FREEDOM CONST E1 LNR 36MM H	ZIMMER BIOMET, INC.	2020-02-11
G7 PPS LTD ACET SHELL 58G	ZIMMER BIOMET, INC.	2020-02-06
G7 SCREW 6.5MM X 35MM	ZIMMER BIOMET, INC.	2020-02-05
G7 SCREW 6.5MM X 20MM	ZIMMER BIOMET, INC.	2020-02-05
G7 SCREW 6.5MM X 35MM	ZIMMER BIOMET, INC.	2020-02-05
G7 SCREW 6.5MM X 20MM	ZIMMER BIOMET, INC.	2020-02-05
G7 SCREW 6.5MM X 35MM	ZIMMER BIOMET, INC.	2020-02-05
G7 SCREW 6.5MM X 20MM	ZIMMER BIOMET, INC.	2020-02-05
G7 SCREW 6.5MM X 20MM	ZIMMER BIOMET, INC.	2020-02-05
G7 HI-WALL E1 LINER 32MM B	ZIMMER BIOMET, INC.	2020-02-03
G7 10 DEG E1 LINER 36MM F	ZIMMER BIOMET, INC.	2020-01-22
G7 APICAL HOLE PLUG	ZIMMER BIOMET, INC.	2020-01-20
G7 PPS LTD ACET SHELL 52E	ZIMMER BIOMET, INC.	2020-01-20
G7 PPS LTD ACET SHELL 46B	ZIMMER BIOMET, INC.	2020-01-13
G7 NEUTRAL E1 LINER 36MM E	ZIMMER BIOMET, INC.	2020-01-13
G7 HI-WALL E1 LINER 32MM D	ZIMMER BIOMET, INC.	2020-01-08
G7 NEUTRAL E1 LINER 28MM D	ZIMMER BIOMET, INC.	2020-01-08
COCR FEM HD 40MM TYPE 1 STD	ZIMMER BIOMET, INC.	2020-01-08
G7 HI-WALL E1 LINER 40MM G	ZIMMER BIOMET, INC.	2020-01-08
G7 NEUTRAL E1 LINER 32MM D	ZIMMER BIOMET, INC.	2020-01-03
G7 STR MONOBLOCK SHELL INSRTR	ZIMMER BIOMET, INC.	2020-01-02
G7 HI-WALL ARCOMXL LNR 32MM E M E	ZIMMER BIOMET, INC.	2019-12-11
TAPERLOC MICROP LAT FMRL 9.0MM	ZIMMER BIOMET, INC.	2019-12-08
G7 PPS LTD ACET SHELL 52E	ZIMMER BIOMET, INC.	2019-11-27
G7 10 DEG ARCOMXL LINER 36MM F	ZIMMER BIOMET, INC.	2019-11-25
G7 NEUTRAL ARCOMXL LNR 36MM F	ZIMMER BIOMET, INC.	2019-11-22
G7 NEUTRAL E1 LINER 32MM C	ZIMMER BIOMET, INC.	2019-11-19
G7 FREEDOM CONST E1 LNR 36MM G	ZIMMER BIOMET, INC.	2019-11-19
G7 HI-WALL E1 LINER 32MM C	ZIMMER BIOMET, INC.	2019-11-19
G7 NEUTRAL E1 LINER 32MM F	ZIMMER BIOMET, INC.	2019-11-18