BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INCIPIO DEVICES

    Reg #: 3011015572 · FEI: 3011015572 · Expires 2026
    View on FDA
    Products
    38
    Proprietary Names
    154
    Establishment Types
    2
    Classifications
    38

    Registration Details

    Registration Name
    INCIPIO DEVICES
    Registration Number
    3011015572
    FEI Number
    3011015572
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3650 West 200 North
    City
    Huntington
    State
    IN
    ZIP
    46750
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142938

    Owner / Operator

    Firm Name
    Incipio Devices
    Operator Number
    10047511
    Address
    3650 W 200 N
    City
    Huntington
    State
    IN
    Postal Code
    46750
    Country
    US
    Correspondent
    Troy Johnson

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO
    Neurological Stereotaxic Instrument HAW
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Reamer HTO
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Wrench HXC
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Probe HXB
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Template HWT
    Orthopedic Manual Surgical Instrument LXH
    Screwdriver HXX
    Clamp HXD
    Guide, Surgical, Instrument FZX
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Tap, Bone HWX
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Prosthesis, Elbow, Constrained, Cemented JDC
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Impactor HWA
    Awl HWJ
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Hammer, Surgical FZY
    Extractor HWB
    Osteotome HWM

    Proprietary Names

    VITAL MIS NAVIGATION CANNULATED TAP 8mm VITAL MIS NAVIGATION CANNULATED TAP 9mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 8.5mm VITAL MIS NAVIGATION CANNULATED TAP 10.5mm VITAL MIS NAVIGATION CANNULATED SCREWDRIVER VITAL MIS NAVIGATION CANNULATED ILIAC TAP 7mm VITAL MIS NAVIGATION CANNULATED TAP 6.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 9.5mm VITAL MIS NAVIGATION CANNULATED TAP 9.5mm VITAL MIS NAVIGATION CANNULATED TAP 8.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 9mm VITAL MIS NAVIGATION CANNULATED TAP 5mm VITAL MIS NAVIGATION STRAIGHT THORACIC PROBE VITAL MIS NAVIGATION CANN SCREWDRIVER, SHORT VITAL MIS NAVIGATION STRAIGHT LUMBAR PROBE VITAL MIS NAVIGATION CANNULATED ILIAC TAP 7.5mm VITAL MIS NAVIGATION CANNULATED TAP 10mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 6.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 6mm VITAL MIS NAVIGATION CANNULATED TAP 4mm VITAL NAVIGATION CANNULATED REDUCTION DRIVER VITAL MIS NAVIGATION CANNULATED ILIAC TAP 10.5mm VITAL MIS NAVIGATION AWL VITAL MIS NAVIGATION CANNULATED TAP 7.5mm VITAL MIS NAVIGATION CANNULATED TAP 6mm VITAL MIS NAVIGATION CANNULATED TAP 7mm VITAL MIS NAVIGATION CANNULATED TAP 4.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 8mm VITAL MIS NAVIGATION CANNULATED TAP 5.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 10mm Persona Partial Knee Instruments 5901-6060 - ReUnion TSA - Single Handle Cannulated Centering Guide Reamer System ZimmerBiomet SEGMENTAL PROXIMAL FEMUR TEMPLATE Persona Revision Counter-Torque Wrench PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER PSN REV FEM SZ/CT GD SPC 10MM PSN REV TIB OFF STM ADP 3/6 MM PSN REV FEM DIST CUT GDE STEM EXTRACTOR PSN REV ROTATION ASSESSMNT GDE PSN REV ALGN ROD ADPT PSN REV TIB STR STM ADPT PSN REV FEM VAL ALGN GDE 6 DEG PSN REV FEM STEM PRV ADPT PSN REV FEM SZ/CT GD SPC 15 MM PSN REV FEM STR ADPT PSN REV FEM DRL GDE 19.5MM PSN REV FEM OFST ADPT 3/6 MM IM TIB RESECTION CUT GUIDE RT PSN REV FEM SZ/CTGD SPC 5 MM PSN REV TIB AUG CUT GDE LT PSN REV EXT TAPER IMPT PSN REV FEM ROT ALGN GDE IM TIB RESECTION BOOM 0 DEG IM TIB RESECTION CUT GUIDE LT PSN REV TIB AUG CUT GDE RT PSN REV TIB DRL GDE 19.5MM PSN REV CNTR-TRQ WRENCH Template Stryker THK Conversion Instruments Guide, Surgical, Instrument Zimmer Persona Personalized Knee System PG HL DRILL GDE HANDLE ASSY FEMORAL PROVISIONAL INSERTER Continuum Trilogy IT Acetabular Systems Trident Rio Straight Shell Impactor Trident Rio Inline-Offset Shell Impactor Comprehensive SRS - Nexel Persona Revision epicondylar alignment guide Persona Revision femoral sizing/cut guide spacer 15 mm Persona Revision femoral offset stem reamer adapter 3/6 mm Persona Revision femoral straight stem reamer adapter Persona Revision femoral distal cut guide Persona Revision femoral sizing/cut guide spacer 5 mm Persona Revision IM tibial resection cut guide LH Persona Revision tibial augment cut guide RH Persona Revision tibial augment cut guide LH Persona Revision femoral drill guide 19.5 mm Persona Revision Knee System Persona Revision tibial straight stem reamer adapter Persona Revision IM tibial resection cut guide RH Persona Revision tibial drill guide 19.5 mm Persona Revision tibial offset stem reamer adapter 3/6 mm Persona Revision femoral sizing/cut guide spacer 10 mm Persona Revision femoral valgus alignment guide 6 deg Persona Revision IM tibial resection boom 0 deg SEG PROX TIB TISSUE ATTACH KIT PROXIMAL FEMUR TEMPLATE 38MM PROXIMAL FEMUR TEMPLATE 46MM SEG TIB TISSUE ATTACH PROV LEFT SEG TIB TISSUE ATTACH PROV RIGHT PERSONA - ROSA Partial Knee System Augment Reamer Guide Inserter Active Plate System Offset Cup Impactor Comprehensive Reverse Shoulder System Mini Humeral Tray +10 Thickness +6mm Taper Offset 40mm Diameter Co-Cr-Mo Comprehensive Reverse Shoulder System Mini Humeral Tray Standard Thickness +6mm Taper Offset 40mm Diameter Ti-6Al-4V Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial +10mm thickness +0mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial +5mm thickness +6mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray Standard Thickness +6mm Taper Offset 40mm Diameter Co-Cr-Mo Comprehensive Reverse Shoulder System Bearing Trial +3mm Thickness 40mm Diameter Comprehensive Reverse Prolong Highly Crosslinked Polyethylene Bearing Standard 40mm Diameter Comprehensive Versa-Dial Reverse Shoulder System, +6mm Lateral Offset 40mm Diameter, Co-Cr-Mo Comprehensive Reverse Highly Crosslinked Polyethylene Bearing +3mm Thickness Diameter40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray +5 Thickness +0mm Taper Offset 40mm Diameter Ti-6Al-4V Comprehensive Reverse Shoulder System Mini Humeral Tray Standard Thickness +0mm Taper Offset 40mm Diameter Ti-6Al-4V Comprehensive Reverse Shoulder System Bearing Trial Standard 40mm Diameter Comprehensive Reverse Prolong Highly Crosslinked Polyethylene Bearing +3mm Retentive Thickness 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray +10 Thickness +3mm Taper Offset 40mm Diameter Ti-^Al-4V Comprehensive Reverse Shoulder System Mini Humeral Tray +5 Thickness +3mm Taper Offset 40mm Diameter Co-Cr-Mo Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial +5mm thickness +3mm Taper Offset 40mm Diameter Comprehensive Versa-Dial Reverse Shoulder System - Glenosphere Trial Standard Offset, +6mm 40mm Diameter Comprehensive Reverse Shoulder System Bearing Trial +3mm Retentive Thickness 36mm Diameter Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial +10mm thickness +6mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray +5 Thickness +3mm Taper Offset 40mm Diameter Ti-6Al-4V Comprehensive Reverse Shoulder System Mini Humeral Tray +10 Thickness +0mm Taper Offset 40mm Diameter Co-Cr-Mo Comprehensive Reverse Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial +10mm thickness +3mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray +10 Thickness +6mm Taper Offset 40mm Diameter Ti-6Al-4V Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial +5mm thickness +0mm Taper Offset 40mm Diameter Comprehensive Versa-Dial Reverse Shoulder System - Glenosphere Trial Standard Offset 40mm Diameter Comprehensive Reverse Vivacit-E Highly Crosslinked Polyethylene Bearing Standard 40mm Diameter Comprehensive Reverse Shoulder System Prolong Highly Crosslinked Polyethylene Bearing Standard 36mm Diameter Comprehensive Versa-Dial Reverse Shoulder System, Standard, Ti-6Al-4V, 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray Standard Thickness +0mm Taper Offset 40mm Diameter Co-Cr-MO Comprehensive Reverse Shoulder System Mini Humeral Tray +10 Thickness +3mm Taper Offset 40mm Diameter Co-Cr-Mo Comprehensive Reverse Shoulder System Bearing Trial +3mm Retentive Thickness 40mm Diameter Comprehensive Reverse Vivacit-E Highly Crosslinked Polyethylene Bearing Standard 36mm Diameter Comprehensive Reverse Shoulder System Bearing Trial +3mm Thickness 36mm Diameter Comprehensive Versa-Dial Reverse Shoulder System - Glenosphere Trial Standard Offset, +3mm Lateral Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray +10 Thickness +0mm Taper Offset 40mm Diameter Ti-6Al-4V Comprehensive Reverse Vivacit-E Highly Crosslinked Polyethylene Bearing +3mm Thickness Diameter 36mm Diameter Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial Standard Thickness +3mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial Standard Thickness +6mm Taper Offset 40mm Diameter Comprehensive Reverse Vivacit-E Highly Crosslinked Polyethylene Bearing +3mm Retentive Thickness 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray +5 Thickness +6mm Taper Offset 40mm Diameter Comprehensive Versa-Dial Reverse Shoulder System, +3mm Lateral Offset 40mm Diameter, Co-Cr-Mo Comprehensive Reverse Shoulder System Mini Humeral Tray Standard Thickness +3mm Taper Offset 40mm Diameter Ti-6Al-4V Comprehensive Reverse Shoulder System Mini Humeral Tray +5 Thickness +6mm Taper Offset 40mm Diameter Co-Cr-Mo Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial +0mm Taper Offset 40mm Diameter Comprehensive Reverse Vivacit-E Highly Crosslinked Polyethylene Bearing +3mm Retentive Thickness 36mm Diameter Comprehensive Reverse Prolong Highly Crosslinked Polyethylene Bearing +3mm Retentive Thickness 36mm Diameter Comprehensive Reverse Shoulder System Bearing Trial Standard 36mm Diameter Comprehensive Versa-Dial Reverse Shoulder System, +3mm Lateral Offset 40mm Diameter, Ti-6Al-4V Comprehensive Versa-Dial Reverse Shoulder System, +6mm Lateral Offset 40mm Diameter, Ti-6Al-4V` Comprehensive Reverse Shoulder System Mini Humeral Tray +5 Thickness +0mm Taper Offset 40mm Diameter Co-Cr-Mo Comprehensive Reverse Shoulder System Mini Humeral Tray Standard Thickness +3mm Taper Offset 40mm Diameter Co-Cr-Mo Comprehensive Reverse Prolong Highly Crosslinked Polyethylene Bearing +3mm Thickness Diameter 36mm Diameter Comprehensive Versa-Dial Reverse Shoulder System, Standard, 40mm Diameter Co-Cr-Mo Comprehensive Reverse Vivacit-E Highly Crosslinked Polyethylene Bearing +3mm Thickness Diameter40mm Diameter Extractor

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device