BEUDAMED
    FDA Registration Active 🇺🇸 United States

    rms Surgical

    Reg #: 3010009693 · FEI: 3010009693 · Expires 2026
    View on FDA
    Products
    69
    Proprietary Names
    87
    Establishment Types
    1
    Classifications
    69

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    Registration Details

    Registration Name
    rms Surgical
    Registration Number
    3010009693
    FEI Number
    3010009693
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1220 Lund Blvd
    City
    Anoka
    State
    MN
    ZIP
    55303
    Country
    US

    Owner / Operator

    Firm Name
    THE CRETEX COMPANIES, INC.
    Operator Number
    9001389
    Address
    311 LOWELL AVE., --
    City
    Elk River
    State
    MN
    Postal Code
    55330
    Country
    US
    Correspondent
    DARREN A KLATT

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Elevator HTE
    Orthopedic Stereotaxic Instrument OLO
    Hook, Surgical, General & Plastic Surgery GDG
    Impactor HWA
    Retractor, All Types EIG
    Starter, Bone Screw HWD
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Instrument, Bending Or Contouring HXP
    Gauge, Depth HTJ
    Clamp HXD
    Guide, Surgical, Instrument FZX
    Nail, Fixation, Bone JDS
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Bit, Drill HTW
    Plate, Fixation, Bone HRS
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Tray, Surgical LRP
    Template HWT
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Mallet HXL
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Driver, Prosthesis HWR
    Tray, Surgical, Instrument FSM
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Instrument, Manual, Surgical, General Use MDM
    Curette HTF
    Screwdriver HXX
    Broach HTQ
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Forceps HTD
    Colonoscope And Accessories, Flexible/Rigid FDF
    Bender HXW
    Osteotome HWM
    Laparoscope, General & Plastic Surgery GCJ
    Endoscope Holder OCV
    Operating Room Accessories Table Tray FWZ
    Forceps, General & Plastic Surgery GEN
    Brace, Drill HXY
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Appliance, Fixation, Spinal Interlaminal KWP
    Posterior Cervical Screw System NKG
    Tap, Bone HWX
    Orthopedic Manual Surgical Instrument LXH
    Burr, Orthopedic HTT
    Reamer HTO
    Hammer, Surgical FZY
    Extractor HWB
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Retractor GAD
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Pliers, Surgical HTC
    Tamp HXG
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO

    Proprietary Names

    V2F ELEVATOR NavitrackER Pliers Zimmer Persona Personalized Knee System Avenir Complete(TM) Hip System ALPS Proximal Humerus Plating System CLAMP 1.6 MM K-WIRE SLEEVE 1.6MM FAST GUIDE ADAPTOR 2mm Measure Drill Sleeve Large BB-TAK, Threaded Endoskeleton TAS Interbody System Endoskeleton TL Interbody System intervertebral fusion device with bone graft, lumbar Z1 Hip System FEMORAL DRIVER/IMPACTOR Harmony Retractor System Harmony (Surgical Port) GTS Trunnion Connection Lid ROSA® Pin Caddy VPC SYSTEM - TRAY BASE NEXEL TOTAL ELBOW INSTRUMENT CASES ROSA® TKA Cut Guide Bracket ROSA® Modular Tray ROSA® Knee General Instrument Case Condyles Digitizer Bracket CASE LID ASSY FULL LENGTH LID ASSY HALF LENGTH CASE ASSEMBLY HALF LENGTH H100 ROSA® NexGen® Knee ID Plate VPC SYSTEM - SCREW CADDY ROSA® Persona® Knee ID Plate CASE ASSEMBLY FULL LENGTH H100 ROSA® PKA Validation Tool Bracket ROSA® Modular Instrument Case ROSA® PPK MED CG AL&BR Bracket ROSA® PPK MED CG AR&BL Bracket Universal Tool Assembly Bracket ROSA® Persona Partial Knee ID Plate ROSA® Vanguard® Knee ID Plate CURETTE PERSONA REVISION KNEE SYSTEM GENERAL Mini MaxTorque Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer A.L.P.S. Clavicle Plating System Persona Revision Knee System Persona Revision Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis OSTEOTOME Walter Scope Holder WalterLorenz Surgical Assist Arm Scope Holder Proximal Humerus Plating System Single/multiple component metallic bone fixation appliances and accessories Endoskeleton TCS Interbody System Posterior Cervical Screw System TAP, BONE Pathfinder NXT (Pedical Screw System) Harmony Posterior Optio-C (Anterior Cervical System) Unicompartmental Knee System Spacer Block 5 Degrees 14 Mm Thickness POST WALL IMPACTOR LEFT 24MM OXF MP 10DEG FMRL DRL GD MED OXF MP 10DEG FMRL DRL GD XL OSTEOTOME IMPACTOR LEFT 21MM OSTEOTOME IMPACTOR RIGHT 24MM 90 DEG OSTEOTOME 10X10MM CURVED OSTOTOME 12MM OXF MP 10DEG FMRL DRL GD XS STRAIGHT OSTOTOME 12MM IMPACTOR OSTEO ASM 24MM R OXF MP 10DEG FMRL DRILL GUIDE HEADLESS PIN PULLER STRAIGHT CURETTE 5MM IMPACTOR OSTEO ASM 21MM L CURVED OSTEOTOME 6MM CUP CURETTE RIGHT 5MM CUP CURETTE LEFT 5MM RASP STRAIGHT MIS FLEX SPACER ADAPTER 3.4MM OXF MP 10DEG FMRL DRL GD LG TELESCOPING LOCKING BOOM IMPACTOR OSTEO ASM 24MM L ROSA PARTIAL KNEE SYSTEM Retractor EMPHASYS Acetabular Cases and Trays Persona® Personalized Knee System Comprehensive Reverse Augmented Baseplate Instrument

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)