FDA Registration
Active
🇺🇸 United States
Complexus Medical
Reg #: 3009887475
·
FEI: 3009887475
·
Expires 2026
Products
52
Proprietary Names
191
Establishment Types
2
Classifications
52
Registration Details
- Registration Name
- Complexus Medical
- Registration Number
- 3009887475
- FEI Number
- 3009887475
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 55980 Russell Industrial Pkwy
- City
- Mishawaka
- State
- IN
- ZIP
- 46545
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181390
Owner / Operator
- Firm Name
- Complexus Medical
- Operator Number
- 10042212
- Address
- 55980 Russell Industrial Parkway
- City
- Mishawaka
- State
- IN
- Postal Code
- 46545
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-01-07 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2018-08-03 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-08-03 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2018-08-03 |
| External Mandibular Fixator And/Or Distractor | MQN | Class 2 | Dental | No | 2013-01-28 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2013-01-28 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2012-12-04 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2012-12-04 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2012-12-04 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-11-01 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-07-11 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-07-11 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-02-05 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2014-02-13 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2014-12-03 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2014-12-03 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2020-05-13 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-02-13 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-02-13 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-03-26 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2013-01-07 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2018-02-05 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2016-04-18 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2019-09-26 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2013-01-28 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2013-01-28 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2013-01-27 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2019-09-26 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2014-12-08 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2014-12-08 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2019-03-27 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2020-07-28 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2016-12-13 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-01-27 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2016-12-13 |
| Probe | HXB | Class 1 | Orthopedic | No | 2014-12-23 |
| Device, Prosthesis Alignment | IQO | Class 1 | Physical Medicine | No | 2013-01-27 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2014-02-14 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2013-01-07 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2014-02-13 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2018-06-22 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2018-02-05 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-07 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-01-07 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2018-02-05 |
| Bender | HXW | Class 1 | Orthopedic | No | 2014-12-23 |
| Template | HWT | Class 1 | Orthopedic | No | 2014-08-20 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-12-13 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2014-02-14 |
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
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
Spine Smith, USA: 011-0108 - DISTAL GEAR WITH T-20 TIP - VisuALIF Challenging Access System
Spine Smith, USA: 0373-0020 - T-20 FIXED ANGLE DRIVER - VisuALIF Challenging Access System
Biomet Spine: 14-500007-00 - Firm Pedicle Sound - Polaris Spinal System
Advance Depth Stylus
14-531594-00 Drill / Awl Spring Sleeve - Biomet Spine
14-531593-00 Drill / Awl Sleeve - Biomet Spine
14-531702-00 Low Pro Awl - Biomet Spine
Apache¿ IBFD / VBR Systems
SLIDE HAMMER ZIMMER NEXEL TOTAL ELBOW
ARTICULATION INSERTER ZIMMER NEXEL TOTAL ELBOW
ULNAR BEARING ASSY TOOL ZIMMER NEXEL TOTAL ELBOW
ULNAR CLEARANCE TEMPLATE ZIMMER NEXEL TOTAL ELBOW
SERVICE TREPHINE GDE B BU NEXGEN CONVERSION INSTRUMENTS
SERVICE TREPHINE GDE D BU NEXGEN CONVERSION INSTRUMENTS
SERVICE TREPHINE GDE E BU NEXGEN CONVERSION INSTRUMENTS
SERVICE TREPHINE GDE F BU NEXGEN CONVERSION INSTRUMENTS
SERVICE TREPHINE GDE C BU NEXGEN CONVERSION INSTRUMENTS
Gender PFJ IM ANTERIOR CUT GUIDE NEXGEN CONVERSION INSTRUMENTS
25mm Qc Dual Rail Distractor
MGII KNEE LOCKING IMPACTOR/EXTRACTOR MIS TKA MINI-KEEL INSTRUMENTS
MIS INSERTER / EXTRACTOR IMPACT PAD
TIBIAL BROACH IMPACTOR ASSEMBLY
MIS FEMORAL INSERTER / EXTRACTOR
Replacement Sliding Stop, acryl
Biomet Spine: 14-510008-00 - Coronal Bending Iron - Left - Polaris Spinal System
Biomet Spine: 14-510009-00 - Coronal Bending Iron - Right - Polaris Spinal System
MULTIPOLAR AND UNIPOLAR HEAD PROVISIONAL SET BASE NO. 5003
FUZION SPACER LEFT MULTIPOLAR AND UNIPOLAR HEAD PROVISIONAL
FUZION SPACER RIGHT MULTIPOLAR AND UNIPOLAR HEAD PROVISIONAL
14-510009-00 Coronal Bending Iron, Right - Biomet Spine
14-510008-00 Coronal Bending Iron, Left - Biomet Spine
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device