Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022142628

FEI Number

3022142628

Entity Name

Smith and Nephew Operations Sdn. Bhd

City/State/Country

Penang Pulau Pinang, MY

Establishment Address

PMT 797, Persiaran Cassia Selatan 8, Taman Perindustrian Batu Kawan, Bandar Cassia, Penang Pulau Pinang 14110, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Smith & Nephew, Inc. (Owner Number: 1020279)

Owner / Operator Contact Address

2875 Railroad Street, Pittsburgh, PA 15222, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K963509

PMA Number

N/A

All Registered Proprietary Names

EVOS EVOS R3 EVOS GENESIS LEGION GENESIS OXINIUM R3 GENESIS TC-100 SCREW AND PLATING SYSTEM CONQUEST FN CANNULATED SCREWS PERI-LOC PERIARTICULAR AND VARIABLE- ANGLE LOCKED PLATING (VLP) SYSTEMS EVOS PLATING SYSTEMS D-RAD PLATING SYSTEM CHS COMPRESSION HIP SCREW CANNULATED SCREWS CHS COMPRESSION HIP SCREW CONQUEST FN D-RAD PLATING SYSTEM EVOS PLATING SYSTEM REFLECTION EVOS EVOS SYNERGY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-12-01
NDG	Washer, Bolt, Nut, Non-Spinal, Metallic	Orthopedic	Class 2	888.3030	2020-12-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-08-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-08-23
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2013-01-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-11-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-11-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-10
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2013-01-10
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2013-01-11
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-01
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-11-07
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2022-11-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-11-07
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2022-11-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-11-07
NDG	Washer, Bolt, Nut, Non-Spinal, Metallic	Orthopedic	Class 2	888.3030	2022-11-07
JDO	Device, Fixation, Proximal Femoral, Implant	Orthopedic	Class 2	888.3030	2022-11-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-01-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-04-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-04-24
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2017-04-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-06-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-06-12
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2014-06-12
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-01-14

Official Correspondent

Lisa Ewing

US Agent Details

Lisa Ewing Email: lisa.ewing@smith-nephew.com Phone: (412) 4199765

Related Public Records

Same Entity

Smith & Nephew, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

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3026368553	INTEGRITY ORTHOPAEDICS, INC.	Maple Plain, MN, US
3012130335	Tusker Medical Inc.	Austin, TX, US
3016090213	Blue Belt Technologies, Inc.	Pittsburgh, PA, US
3012358417	Arthrocare Corporation	Coyol Alajuela, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223112	Smith & Nephew, Inc.	MAVERICK Mini External Fixation System	2022-12-08
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25

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-0003-2019	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-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022142628. Last updated year: 2026. Please use registration number 3022142628 when referencing this establishment in official correspondence.