Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011274144

FEI Number

3011274144

Entity Name

WESTLAKE PLASTICS EUROPE

City/State/Country

TOURCOING Nord, FR

Establishment Address

2 rue de Maestricht, TOURCOING Nord 59200, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

WESTLAKE PLASTICS EUROPE (Owner Number: 10048274)

Owner / Operator Contact Address

2 rue de Maestricht, TOURCOING, FR-59 59200, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PHYSICA KR KNEE SYSTEM SMR Hybrid Glenoid System MASTER SL FEMORAL STEM AGILON® XO retentive trial cap AGILON® XO inverse trial cap AGILON® XO trial glenosphere 32mm neutral AGILON® XO trial glenosphere 40mm eccentric AGILON® XO trial glenosphere 36mm eccentric AGILON® XO trial glenosphere 36mm neutral Tornier Perform® Humeral System Salto Talaris Total Ankle Prosthesis PB Uni PE impaction adapter Tornier Perform® Anatomic Glenoid Tornier Radial Head System Tornier Flex Shoulder System Aequalis® Reversed Fracture Aequalis® Reversed II Reunion Aequalis Instrument Orthopedic manual surgical instrument PB Uni tibial impaction clip TRAX CR Total Knee System - Instruments ACS® FB trial PE insert SC 4/13,75mm ACS® FB trial PE insert hyperflex 4/11,25mm ACS® FB trial PE insert ultra 2/13,75mm ACS® FB trial PE insert ultra 3/13,75mm ACS® FB trial PE insert hyperflex 6/12,5mm ACS® FB trial PE insert SC 3/11,25mm ACS® FB trial PE insert hyperflex 6/11,25mm ACS® FB trial PE insert hyperflex 2/11,25mm ACS® FB trial PE insert hyperflex 5/12,5mm ACS® FB trial PE insert hyperflex 2/13,75mm Salto Talaris Total Ankle Prosthesis Aequalis® Reversed Fracture ACS® FB trial PE insert ultra 4 12,5mm MK trial femoral spacer distal rl/lm 4/10mm ACS® FB trial PE insert PS 2/10mm ACS® FB trial PE insert PS 2/12,5mm MK trial femoral spacer posterior 4/10mm MK trial femoral spacer posterior 5/5mm ACS® FB trial PE insert 3/11,25mm MK trial femoral spacer distal ll/rm 2,5/10mm ACS® FB tibial trial spacer ll/rm 3,5/5mm ACS® FB trial PE insert PS 5/10mm ACS® FB trial PE insert SC 5/10mm ACS® FB tibial trial spacer rl/lm 6/5mm ACS® FB trial PE insert PS 3/11,25mm MK trial femoral spacer distal ll/rm 5/5mm ACS® FB tibial trial spacer ll/rm 2/5mm ACS® FB trial PE insert PS 6/13,75mm ACS® FB tibial trial spacer ll/rm 2,5/10mm ACS® FB tibial trial adapter 4 17,5mm AGILON® XO trial glenoid sz. 4 ACS® FB tibial trial adapter 4 15mm ACS® FB tibial trial spacer rl/lm 3/5mm ACS® FB trial PE insert 4/13,75mm ACS® FB tibial trial spacer ll/rm 4/10mm ACS® FB tibial trial adapter 2 17,5mm MK trial femoral spacer distal rl/lm 2/10mm ACS® FB trial PE insert SC 3/10mm ACS® PE patella trial 26mm ACS® FB tibial trial spacer rl/lm 3,5/10mm ACS® FB trial PE insert PS 6/10mm ACS® FB tibial trial spacer rl/lm 4/10mm ACS® FB tibial trial spacer ll/rm 3/10mm ACS® FB trial PE insert PS 4/11,25mm MK trial femoral spacer posterior 2/5mm ACS® FB trial PE insert PS 6/12,5mm ACS® FB tibial trial adapter 2 15mm MK trial femoral spacer posterior 6/10mm ACS® FB tibial trial spacer rl/lm 5/5mm ACS® FB tibial trial spacer ll/rm 3/5mm ACS® FB trial PE insert PS 4/13,75mm ACS® FB trial PE insert hyperflex 3/10mm AGILON® XO trial glenoid sz. 2 MK trial femoral spacer distal ll/rm 2/5mm ACS® FB trial PE insert ultra 2/10mm ACS® FB tibial trial spacer ll/rm 6/5mm ACS® FB tibial trial adapter 6 15mm ACS® FB trial PE insert PS 3/10mm MK trial femoral spacer distal rl/lm 5/10mm ACS® FB tibial trial adapter 6 17,5mm MK trial femoral spacer posterior 3/10mm ACS® FB trial PE insert PS 6/11,25mm MK trial femoral spacer distal rl/lm 2,5/10mm ACS® FB trial PE insert SC 3/12,5mm ACS® FB tibial trial spacer rl/lm 2/5mm AGILON® XO trial glenoid sz. 3 ACS® FB trial PE insert hyperflex 5/10mm ACS® FB trial PE insert ultra 6 12,5mm ACS® FB trial PE insert hyperflex 4/12,5mm ACS® FB trial PE insert ultra 3 12,5mm MK trial femoral spacer distal rl/lm 2,5/5mm ACS® FB tibial trial spacer rl/lm 4/5mm MK trial femoral spacer posterior 2/10mm ACS® FB tibial trial adapter 2 20mm ACS® FB tibial trial spacer ll/rm 2/10mm ACS® FB trial PE insert 2/11,25mm ACS® FB tibial trial adapter 6 20mm MK trial femoral spacer distal ll/rm 5/10mm MK trial femoral spacer posterior 4/5mm MK trial femoral spacer distal rl/lm 4/5mm ACS® FB trial PE insert 2/13,75mm ACS® FB tibial trial spacer rl/lm 3/10mm ACS® FB trial PE insert ultra 3 10mm ACS® FB trial PE insert 5/13,75mm ACS® FB trial PE insert SC 2/11,25mm ACS® FB trial PE insert SC 2/13,75mm ACS® FB trial PE insert hyperflex 6/13,75mm ACS® FB trial PE insert SC 3/13,75mm ACS® FB trial PE insert SC 6/11,25mm MK trial femoral spacer posterior 2,5/5mm ACS® FB trial PE insert SC 6/12,5mm ACS® PE patella trial 35mm ACS® FB tibial trial adapter 5 20mm ACS® PE patella trial 29mm MK trial femoral spacer distal ll/rm 6/5mm ACS® FB tibial trial spacer rl/lm 2,5/10mm MK trial femoral spacer distal ll/rm 2/10mm ACS® FB trial PE insert ultra 2/11,25mm ACS® FB trial PE insert hyperflex 6/10mm ACS® FB trial PE insert ultra 5/11,25mm ACS® FB trial PE insert hyperflex 3/12,5mm ACS® FB trial PE insert hyperflex 5/13,75mm ACS® FB trial PE insert ultra 4/11,25mm ACS® FB trial PE insert ultra 5/13,75mm ACS® FB trial PE insert PS 2/13,75mm ACS® FB trial PE insert ultra 2 12,5mm MK trial femoral spacer distal ll/rm 3/10mm ACS® FB trial PE insert ultra 6/13,75mm ACS® FB tibial trial spacer rl/lm 2,5/5mm MK trial femoral spacer distal rl/lm 2/5mm ACS® FB trial PE insert SC 5/12,5mm ACS® FB trial PE insert PS 5/13,75mm ACS® FB tibial trial spacer ll/rm 3,5/10mm ACS® FB trial PE insert hyperflex 4/10mm ACS® FB trial PE insert hyperflex 4/13,75mm ACS® FB trial PE insert SC 4/12,5mm MK trial femoral spacer posterior 2,5/10mm ACS® FB trial PE insert ultra 6 10mm ACS® FB trial PE insert PS 3/12,5mm ACS® FB tibial trial spacer ll/rm 5/5mm ACS® FB trial PE insert 5/11,25mm ACS® FB tibial trial spacer rl/lm 6/10mm ACS® PE patella trial 32mm ACS® FB trial PE insert 3/13,75mm ACS® FB tibial trial adapter 4 20mm ACS® FB tibial trial adapter 5 15mm ACS® FB tibial trial spacer ll/rm 4/5mm MK trial femoral spacer distal rl/lm 5/5mm ACS® FB trial PE insert SC 4/10mm ACS® FB tibial trial spacer ll/rm 2,5/5mm ACS® FB trial PE insert 4/11,25mm ACS® FB tibial trial spacer ll/rm 5/10mm ACS® FB trial PE insert PS 2/11,25mm ACS® FB tibial trial adapter 5 17,5mm ACS® FB trial PE insert PS 3/13,75mm ACS® FB tibial trial spacer ll/rm 6/10mm ACS® FB tibial trial adapter 3 17,5mm AGILON® XO trial glenoid sz. 1 ACS® FB trial PE-insert hyperflex 5/11,25mm MK trial femoral spacer distal rl/lm 6/10mm ACS® FB trial PE insert PS 4/10mm ACS® FB trial PE insert ultra 5 10mm ACS® FB tibial trial spacer rl/lm 5/10mm MK trial femoral spacer distal ll/rm 4/10mm MK trial femoral spacer posterior 3/5mm MK trial femoral spacer distal ll/rm 6/10mm MK trial femoral spacer distal rl/lm 3/5mm ACS® FB tibial trial adapter 3 20mm ACS® FB trial PE insert PS 5/11,25mm ACS® FB tibial trial spacer rl/lm 3,5/5mm ACS® FB trial PE insert PS 4/12,5mm MK trial femoral spacer distal rl/lm 3/10mm ACS® FB trial PE insert SC 5/13,75mm MK trial femoral spacer distal ll/rm 2,5/5mm ACS® FB trial PE insert PS 5/12,5mm MK trial femoral spacer distal ll/rm 3/5mm ACS® FB trial PE insert 6/11,25mm MK trial femoral spacer distal rl/lm 6/5mm ACS® FB trial PE insert ultra 5 12,5mm ACS® FB tibial trial spacer rl/lm 2/10mm ACS® FB trial PE insert hyperflex 3/13,75mm MK trial femoral spacer posterior 5/10mm ACS® FB trial PE insert ultra 4 10mm MK trial femoral spacer distal ll/rm 4/5mm ACS® FB tibial trial adapter 3 15mm ACS® FB trial PE insert SC 6/10mm ACS® FB trial PE insert SC 2/12,5mm ACS® FB trial PE insert SC 2/10mm MK trial femoral spacer posterior 6/5mm ACS® FB trial PE insert 6/13,75mm ACS® FB trial PE insert SC 5/11,25mm ACS® FB trial PE insert ultra 6/11,25mm ACS® FB trial PE insert hyperflex 3/11,25mm ACS® FB trial PE insert SC 6/13,75mm ACS® FB trial PE insert ultra 4/13,75mm ACS® FB trial PE insert ultra 3/11,25mm ACS® FB trial PE insert SC 4/11,25mm Physica CR Knee System Uni FB tibial trial insert 0/9mm Uni FB PE-insert 1/8 mm Uni FB tibial insert 2/10mm Uni FB PE-insert 0/8mm Uni FB tibial insert 4/10mm Uni FB PE-insert 4/9 mm Uni FB tibial trial insert 1/14mm Uni FB tibial insert 3/10mm Uni FB tibial trial insert 0/10mm Uni FB PE-insert 4/11 mm Uni FB tibial trial insert 0/14mm Uni FB trial insert 2/8mm Uni FB PE-insert 4/14mm Uni FB PE-insert 0/11mm Uni FB tibial trial insert 0/8mm Uni FB PE-insert 2/12mm Uni FB tibial insert 3/11mm Uni FB PE-insert 4/8 mm Uni FB PE-insert 1/11 mm Uni FB PE-insert 2/11 mm Uni FB tibial trial insert 2/12mm Uni FB PE-insert 3/8 mm Uni FB PE-insert 3/12mm Uni FB PE-insert 1/14mm Uni FB PE-insert 3/14mm Uni FB tibial trial insert 4/12mm Uni FB tibial trial insert 3/12mm Uni FB tibial trial insert 2/14mm Uni FB PE-insert 2/10 mm Uni FB PE-insert 1/10 mm Uni FB trial insert 1/9mm Uni FB tibial insert 1/10mm Uni FB PE-insert 1/12mm Uni FB PE-insert 4/10 mm Uni FB tibial insert 1/11mm Uni FB PE-insert 3/9 mm Uni FB PE-insert 2/9 mm Uni FB tibial insert 4/11mm Uni FB PE-insert 0/14mm Uni FB PE-insert 2/8 mm Uni FB trial insert 3/8mm Uni FB trial insert 1/8mm Uni FB tibial trial insert 0/11mm Uni FB trial insert 4/9mm Uni FB tibial trial insert 1/12mm Uni FB PE-insert 0/12mm Uni FB PE-insert 2/14mm Uni FB PE-insert 3/11 mm Uni FB tibial insert 2/11mm Uni FB tibial trial insert 4/14mm Uni FB PE-insert 0/9mm Uni FB tibial insert 2/9mm Uni FB trial insert 3/9mm Uni FB tibial trial insert 3/14mm Uni FB tibial trial insert 0/12mm Uni FB tibial trial 4/8mm Uni FB PE-insert 3/10 mm Uni FB PE-insert 4/12mm Uni FB PE-insert 0/10mm Uni FB PE-insert 1/9 mm SMR Stemless Anatomic SMR TT Metal Back Glenoid Bone Graft instruments bipolar head sizing shell trial head taper 12/14mm PRIMA TT Glenoid NAIL 14G PERINE GRID 14G LIN LEAD 14G or LIN LEAD 18G CON LEAD 14G or CON LEAD 18G STEADY PRO SUPPORT FOR FULL 3D ENDOCAVITY SIDE FIRE PROBE (v3.2) NAIL 18G PERINE FULL GRID 14G PERINE NAIL 14G or PERINE NAIL 18G STEADY PRO SUPPORT FOR FULL 3D ENDOCAVITY END FIRE PROBE (v3.2) PERINE FULL GRID 18G STEADY PRO SUPPORT FOR FULL 3D ENDOCAVITY SIDE FIRE PROBE (v3.3) PERINE GRID 18G SMR Shoulder System trial insert 15° neutral 0mm 36/44mm trial insert 15° 4mm offset 36/44mm trial insert 0° 4mm offset 36/52mm trial insert 15° neutral 0mm 36/48mm trial insert 0° 4mm offset 36/44mm trial insert 15° 4mm offset 36/48mm trial insert 0° 4mm offset 32/39mm trial insert 15° 4mm offset 36/52mm trial insert 15° neutral 0mm 32/39m trial insert 0° 4mm offset 36/48mm trial insert 15° neutral 0mm 36/52mm trial insert 15° 4mm offset 32/39mm SMR 3-Pegs Glenoids Flex Shoulder System ACS® PE-patella cemented 29 mm ACS® spacer shim 11,25mm ACS® spacer shim 13,75mm MK spacer for femoral positioner 5mm ACS® PE-patella cemented 32 mm ACS® PE-patella cemented 35 mm ACS® PE-patella cemented 26 mm ACS® SC FB tibial offset alignment MK spacer for femoral positioner 10mm TRAX CR Total Knee System Delta Dual Mobility System AGILON® XO PE-glenoid cemented 2 AGILON® XO PE-glenoid cemented 3 AGILON® XO PE-glenoid cemented 1 AGILON® XO PE-glenoid cemented 4 Delta TT Cups; Delta Liners Delta TT Pro SMR 3-PEGS GLENOIDS trial head taper 12/14mm TEMA Elbow System MADISON SMR 40MM GLENOSPHERE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-12-23
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2024-12-23
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-12-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-12-23
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2024-12-23
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2024-12-23
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2024-12-23
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-12-23
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-12-23
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2024-12-23
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-12-23
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2021-01-27
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-01-27
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-07-04
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2018-06-18
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-12-11
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2023-12-11
HWT	Template	Orthopedic	Class 1	888.4800	2017-04-11
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-12-23
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2021-01-27
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2024-12-23
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-12-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-12-23
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2024-12-23
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2020-09-24
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2024-12-23
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-12-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-04-07
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-12-23
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-12-23
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-01-07
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-12-23
HTO	Reamer	Orthopedic	Class 1	888.4540	2023-11-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-01-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-01-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-12-23
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2024-12-23
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-12-23
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2025-01-07
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2024-12-23
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-12-23
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2024-12-23
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-12-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-12-23
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-09-15
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	Orthopedic	Class 2	888.3160	2024-12-23
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2024-12-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-01-29
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-12-23
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-12-23

Official Correspondent

No official correspondent registered.

US Agent Details

Yared Mengistu Business: Westlake Plastics Company Email: yared.mengistu@westlakeplastics.com Phone: (610) 4591000

Related Public Records

Same Entity

WESTLAKE PLASTICS EUROPE

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25
K153310	Total Joint Orthopedics, Inc.	Klassic Knee System	2015-12-17
K102380	Wrightmedicaltechnologyinc	EVOLUTION MP TOTAL KNEE SYSTEM	2011-01-07
K122985	Aesculap Implant System, Inc.	COLUMBUS REVISION KNEE SYSTEM	2012-10-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0013-06	Plus Orthopedics USA	2	TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011274144. Last updated year: 2026. Please use registration number 3011274144 when referencing this establishment in official correspondence.