Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009887475

FEI Number

3009887475

Entity Name

Complexus Medical

City/State/Country

Mishawaka, IN, US

Establishment Address

55980 Russell Industrial Pkwy, Mishawaka, IN 46545, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Complexus Medical (Owner Number: 10042212)

Owner / Operator Contact Address

55980 Russell Industrial Parkway, Mishawaka, IN 46545, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FEMORAL SPANNER WRENCH SIZE B PSN PS-CPS BOX PROV R SZ 4-5 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS PSN PS-CPS Box Prov Sz 1-L PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS PSN PS-CPS BOX PROV R SZ 12 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS PSN PS-CPS BOX PROV L SZ 3 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS PSN PS-CPS BOX PROV R SZ 10-11 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS PSN PS-CPS BOX PROV R SZ 3 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS PSN PS-CPS BOX PROV L SZ 8-9 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS PSN PS-CPS BOX PROV L SZ 12 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS PSN PS-CPS BOX PROV R SZ 6-7 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS PSN PS-CPS BOX PROV L SZ 4-5 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS PSN PS-CPS BOX PROV L SZ 10-11 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS PSN PS-CPS Box Prov Sz 1-R PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS PSN PS-CPS BOX PROV L SZ 6-7 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS PSN PS-CPS BOX PROV R SZ 8-9 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS Set Screw Dog Point M4x5, Blue Device 180mm Carbon Rod, Blue Device Depth Gage 2/2.4 45mm, long Depth Gage 1.5/2, 45mm, long Zimmer Trabecular Metal Reverse Shoulder System Zimmer Trabecular Metal Total Ankle EM DIST TELESCOPING TUBE GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS NEXGEN BROACH IMPACTOR GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS PATELLA PEG DRILL GUIDE SIZE 38 GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS PATELLA PEG DRILL GUIDE SIZE 32 GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS PATELLA PEG DRILL GUIDE SIZE 41 GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS EM PROX TELESCOPING ROD GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS Persona Adj Res Tower GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS Persona 8mm IM Rod GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS PATELLA PEG DRILL GUIDE SIZE 26 GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS PATELLA PEG DRILL GUIDE SIZE 35 GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS PATELLA PEG DRILL GUIDE SIZE 29 GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS EM MODULAR SPIKE ARM POST GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS Persona 9mm Distal Res Pl GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS SEGMENT INSERTER / REMOVE GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS PERSONA MODULAR HANDLE GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS Persona Valgus Align Gde GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS LINER ELEVATOR GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS EM MODULAR SPIKE ARM GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS NK FLX FEM SIZER GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS Persona 0 Deg Dist Cut Bl GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS NEXGEN RH KNEE TIBIAL BROACH IMPACTOR GENDER SOLUTIONS NATURAL-KNEE FLEX INSTRUMENTS 5.5/6 Mni Reducer 01-1003-5000 Apache¿ Star Cervical PEEK Baxano: 22-0492 - 7.5mm MEASURING DILATOR - Axialif Plus Baxano: 22-0462 - TABLE MOUNTED RETRACTOR ARM - VEO G-H FEM PROV CUTTING GDE PLATE NEXGEN CONVERSION INSTRUMENTS E-F FEM PROV CUTTING GDE PLATE NEXGEN CONVERSION INSTRUMENTS SZ E LT LPS-FLEX MOD BOX PROV NEXGEN CONVERSION INSTRUMENTS SZ G LT LPS-FLEX MOD BOX PROV NEXGEN CONVERSION INSTRUMENTS SZ C LT LPS-FLEX MOD BOX PROV NEXGEN CONVERSION INSTRUMENTS C-D FEM PROV CUTTING GDE PLATE NEXGEN CONVERSION INSTRUMENTS SZ E RT LPS-FLEX MOD BOX PROV NEXGEN CONVERSION INSTRUMENTS SZ G RT LPS-FLEX MOD BOX PROV NEXGEN CONVERSION INSTRUMENTS SZ D RT LPS-FLEX MOD BOX PROV NEXGEN CONVERSION INSTRUMENTS SZ D LT LPS-FLEX MOD BOX PROV NEXGEN CONVERSION INSTRUMENTS SZ C RT LPS-FLEX MOD BOX PROV NEXGEN CONVERSION INSTRUMENTS SZ F RT LPS-FLEX MOD BOX PROV NEXGEN CONVERSION INSTRUMENTS SZ F LT LPS-FLEX MOD BOX PROV NEXGEN CONVERSION INSTRUMENTS Neuro Plate Holding Wand 2 Plate Hold on Cannula, Sm PSN REV FEM BOX PRV RH 11/11+ PSN REV FEM BOX PRV LH 1/1+ PSN REV FEM BOX PRV LH 7/7+ PSN REV FEM BOX PRV RH 3/3+ PSN REV FEM BOX PRV LH 5/5+ PSN REV FEM BOX PRV RH 13/13+ PSN REV T-HANDLE PSN REV REAMER ALIGN GUIDE PSN REV FEM BOX PRV LH 11/11+ PSN REV QC HANDLE PSN REV FEM BOX PRV RH 5/5+ PSN REV FEM BOX PRV RH 7/7+ PSN REV FEM BOX PRV LH 9/9+ PSN REV FEM BOX PRV LH 13/13+ PSN REV DR HANDLE PSN REV FEM BOX PRV RH 9/9+ PSN REV FEM BOX PRV RH 1/1+ PSN REV FEM BOX PRV LH 3/3+ Comprehensive Reverse Shoulder Locking Stem Extractor Bar CoCr Rods for use in the TiLock Pedicle Screw System Genesys Spine Helios¿ Anterior Cervical Plate System Maxx Ortho: RDUUXX00-RK - LINER SECURING PIN - Freeedom PCK Components PERSONA PS BOX CUT GUIDE10-12 ZIMMER PERSONA KNEE SYSTEM PERSONA PS BOX PROVISIONAL 3-5 LEFT ZIMMER PERSONA KNEE SYSTEM PERSONA PS BOX CUT GUIDE3-5 ZIMMER PERSONA KNEE SYSTEM PERSONA FEMORAL INSERTER/EXTRACTOR ZIMMER PERSONA KNEE SYSTEM PSN PS BOX PROV 1-2 L NRW ZIMMER PERSONA KNEE SYSTEM PERSONA PS BOX PROVISIONAL 10-12 LEFT ZIMMER PERSONA KNEE SYSTEM PERSONA PS BOX PROVISIONAL 6-9 RIGHT ZIMMER PERSONA KNEE SYSTEM PERSONA CEMENTED TIBIAL BROACH INSERTER/EXTRACTOR ZIMMER PERSONA KNEE SYSTEM PERSONA ARTICULAR SURFACEINSERTER ZIMMER PERSONA KNEE SYSTEM PERSONA PS BOX CUT GUIDE6-9 ZIMMER PERSONA KNEE SYSTEM PERSONA PS BOX PROVISIONAL 10-12 RIGHT ZIMMER PERSONA KNEE SYSTEM PSN PS BOX PROV 1-2 R NRW ZIMMER PERSONA KNEE SYSTEM PERSONA CEMENTED TIBIAL DRILL GUIDE - 15.7MM ZIMMER PERSONA KNEE SYSTEM PERSONA PS BOX PROVISIONAL 6-9 LEFT ZIMMER PERSONA KNEE SYSTEM PERSONA PS BOX PROVISIONAL 3-5 RIGHT ZIMMER PERSONA KNEE SYSTEM Persona TM TibInserter Personal TM Tibia Inserter-Modifications 20-8020-037-00 Rosa Polyaxial Reference Size 3 20-8020-038-00 Rosa Polyaxial Reference Size 6 ANKLE CLAMP Apache¿ Lateral Lumbar IBFD Sl Screw Measuring Caliper Persona Partial Knee Anat Tibial Sizer, Medial, Size B/C Persona Partial Knee Anat Tibial Sizer, Medial, Size H/J Persona Partial Knee Anat Tibial Sizer, Medial, Size F/G Persona Partial Knee Anat Tibial Sizer, Medial, Size D/E Maxx Ortho: MLCRXF309-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLCRXE517-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLCRXC309-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLPSXD114-K- Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLPSXA109-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLCRXF717-K- Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLCRXG517-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLCRXE309-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLCRXG509-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLPSXD111-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLPSXD109-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLCRXG514-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLPSXD314-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLPSXD311-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLCRXF711-K- Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLPSXC111-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLCRXF709-K- Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLCRXF317-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLPSXD111-K- Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLCRXF314-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLCRXF311-K - Freedom Total Knee Metal Backed Tibial Components Maxx Ortho: MLCRXF714-K- Freedom Total Knee Metal Backed Tibial Components Bi-phase Trocar Trocar Trocar Handle Rapidfire Upper Driver Assembly PERSONA CEMENTED TIBIAL DRILL GUIDE - 15.7MM ZIMMER PERSONA KNEE SYSTEM Genesys Spine: GLC414 - MIS Friction Clip Driver - TiLock Pedicle Screw System Genesys Spine: GL216 - NAV Pedicle Screw Driver - TiLock Pedicle Screw System Genesys Spine: GLC414 - MIS TTS Rod Inserter - TiLock Pedicle Screw System Genesys Spine: GLC430 - MIS Extended Rod Caliper - TiLock Pedicle Screw System Aesculap, SC444R - Quintex All-in-one DBL GD SLV - Drill Guide Advance A/P Sizing Caliper Persona Partial Knee Slap Hammer Biomet, Warsaw: 14-451532-00, Limited Collapse Inserter - TSP HIP Fracture Plating System PERSONA ARTICULAR SURFACEINSERTER PERSONA CEMENTED TIBIAL BROACH INSERTER/EXTRACTOR PSN REV Slaphammer PSN PK Spacer BLK 9MM PSN PK Spacer BLK 10MM PSN PK Spacer BLK 12MM PSN PK Spacer BLK 8MM PSN PK Spacer BLK 14MM Genesys Spine: GCP227 - H2 Cervical Tap - Binary Anterior Cervical Plate System Contra Driver Small Patient Advancement Driver Zimmer Biomet AO 3.5mm Hex Driver BT424412-00 Qc Patient Driver Lactosorb 1.5 Dr Driver Aveolar Patient Driver Lactosorb Direct Driver Blade Advance Primary Femoral ID Tag Removal Tool

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-01-07
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2018-08-03
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-08-03
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2018-08-03
MQN	External Mandibular Fixator And/Or Distractor	Dental	Class 2	872.4760	2013-01-28
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2013-01-28
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2012-12-04
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2012-12-04
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2012-12-04
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-11-01
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-07-11
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-07-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-02-05
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2014-02-13
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-12-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-12-03
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2012-12-04
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-28
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2018-11-13
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2018-11-13
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-11-13
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-05-13
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-05-13
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-02-13
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-02-13
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2014-02-13
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-02-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-02-05
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-12-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-12-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-03-26
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2013-01-07
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2018-02-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-02-13
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2016-04-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-07
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2019-09-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-12-23
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2013-01-28
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2013-01-28
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-02-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-02-13
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2014-02-13
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-02-13
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-12-01
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-12-13
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-12-13
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-12-13
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-12-13
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-12-13
KTZ	Caliper	Orthopedic	Class 1	888.4150	2013-01-27
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-09-26
JDO	Device, Fixation, Proximal Femoral, Implant	Orthopedic	Class 2	888.3030	2014-12-08
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2014-12-08
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-06-25
HWB	Extractor	Orthopedic	Class 1	888.4540	2019-03-27
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2020-07-28
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2016-12-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-12-13
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-12-02
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-01-27
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Complexus Medical

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
K222566	Zimmer, Inc.	Zimmer Persona Personalized Knee System	2022-10-17
K252044	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	Triathlon® Total Knee System - Triathlon® Gold Femoral Components	2025-10-24
K243247	Zimmer, Inc.	Persona the Personalized Knee System	2024-10-29
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25

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-0003-2017	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 3009887475. Last updated year: 2026. Please use registration number 3009887475 when referencing this establishment in official correspondence.