Complexus Medical

Contract manufacturer · Mishawaka, IN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2012Product codes first listed, by year (tallest: 16)2026

FDA registration: 3009887475 (openFDA record; or search FDA's registration database)
FEI number: 3009887475
Registered for: FDA registration year 2026
Establishment types: Manufacturer; Contract manufacturer
Owner or operator: Complexus Medical (FDA owner/operator no. 10042212)
Registered address: 55980 Russell Industrial Pkwy, Mishawaka, IN 46545
Contract listings: 71 device listings, 56 product codes, first listed Nov 1, 2012
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
EIL	Gauge, Depth, Instrument, Dental	Class I	Dental	Contract manufacturing	Jan 28, 2013
EJB	Handle, Instrument, Dental	Class I	Dental	Contract manufacturing	Jan 28, 2013
FSM	Tray, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Jan 28, 2013
FZX	Guide, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Jan 7, 2013
FZY	Hammer, Surgical	Class I	General and plastic surgery	Contract manufacturing	Sep 26, 2019
GAD	Retractor	Class I	General and plastic surgery	Contract manufacturing	Feb 5, 2018
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Jan 7, 2013
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class II	Orthopedic	Contract manufacturing	Dec 4, 2012
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 7, 2013
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Sep 26, 2019
HTJ	Gauge, Depth	Class I	Orthopedic	Contract manufacturing	Jul 28, 2020
HTQ	Broach	Class I	Orthopedic	Contract manufacturing	Feb 5, 2018
HTZ	Instrument, Cutting, Orthopedic	Class I	General and plastic surgery	Contract manufacturing	Feb 5, 2018
HWA	Impactor	Class I	Orthopedic	Contract manufacturing	Jan 7, 2013
HWB	Extractor	Class I	Orthopedic	Contract manufacturing	Mar 27, 2019
HWJ	Awl	Class I	Orthopedic	Contract manufacturing	Feb 14, 2014
HWM	Osteotome	Class I	General and plastic surgery	Contract manufacturing	Jul 29, 2026
HWT	Template	Class I	Orthopedic	Contract manufacturing	Aug 20, 2014
HXB	Probe	Class I	Orthopedic	Contract manufacturing	Dec 23, 2014
HXC	Wrench	Class I	Orthopedic	Contract manufacturing	Jan 7, 2013
HXD	Clamp	Class I	General and plastic surgery	Contract manufacturing	Jan 7, 2013
HXP	Instrument, Bending Or Contouring	Class I	Orthopedic	Contract manufacturing	Feb 14, 2014
HXW	Bender	Class I	Orthopedic	Contract manufacturing	Dec 23, 2014
HXX	Screwdriver	Class I	Orthopedic	Contract manufacturing	Jan 27, 2013
IQO	Device, Prosthesis Alignment	Class I	Physical medicine	Contract manufacturing	Jan 27, 2013
JDC	Prosthesis, Elbow, Constrained, Cemented	Class II	Orthopedic	Contract manufacturing	Jun 22, 2018
JDO	Device, Fixation, Proximal Femoral, Implant	Class II	Orthopedic	Contract manufacturing	Dec 8, 2014
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Dec 4, 2012
KTE	Trocar, Ent	Class I	Ear, nose and throat	Contract manufacturing	Jan 28, 2013
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	Contract manufacturing	Dec 8, 2014
KTZ	Caliper	Class I	Orthopedic	Contract manufacturing	Jan 27, 2013
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract manufacturing	Dec 13, 2016
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract manufacturing	Feb 13, 2014
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Dec 4, 2012
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Dec 4, 2012
LRP	Tray, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jan 28, 2013
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Nov 1, 2012
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract manufacturing	Feb 13, 2014
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Class II	Orthopedic	Contract manufacturing	Jul 29, 2026
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Dec 4, 2012
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract manufacturing	Jan 28, 2013
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract manufacturing	Feb 13, 2014
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract manufacturing	Feb 13, 2014
MQN	External Mandibular Fixator And/Or Distractor	Class II	Dental	Contract manufacturing	Jan 7, 2013
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract manufacturing	Feb 13, 2014
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract manufacturing	Feb 13, 2014
NKG	Posterior Cervical Screw System	Class II	Orthopedic	Contract manufacturing	Dec 13, 2016
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract manufacturing	Feb 13, 2014
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Class II	Orthopedic	Contract manufacturing	Aug 3, 2018
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Dec 13, 2016
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Class II	Orthopedic	Contract manufacturing	Dec 13, 2016
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract manufacturing	Dec 23, 2014
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class II	Orthopedic	Contract manufacturing	Apr 18, 2016
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Class II	Orthopedic	Contract manufacturing	Aug 24, 2026
PHX	Shoulder Prosthesis, Reverse Configuration	Class II	Orthopedic	Contract manufacturing	May 13, 2020
PLR	Spinal Vertebral Body Replacement Device - Cervical	Class II	Orthopedic	Contract manufacturing	Aug 24, 2026