BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INTELIVATION TECHNOLOGIES, LLC

    Reg #: 3019356409 · FEI: 3019356409 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    95
    Establishment Types
    4
    Classifications
    27

    Registration Details

    Registration Name
    INTELIVATION TECHNOLOGIES, LLC
    Registration Number
    3019356409
    FEI Number
    3019356409
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    500 S Gravers Rd, Suite 200
    City
    Plymouth Meeting
    State
    PA
    ZIP
    19462
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212389

    Owner / Operator

    Firm Name
    Intelivation Technologies LLC.
    Operator Number
    10081899
    Address
    500 S Gravers Rd., Ste 200
    City
    Plymouth Meeting
    State
    PA
    Postal Code
    19462
    Country
    US
    Correspondent
    Mark Moldavsky

    Products

    Device Name Product Code
    Gauge, Depth HTJ
    Holder, Needle; Orthopedic HXK
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Rasp HTR
    Guide, Surgical, Instrument FZX
    Bender HXW
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Impactor HWA
    Pin, Fixation, Smooth HTY
    Pin, Fixation, Threaded JDW
    Thoracolumbosacral Pedicle Screw System NKB
    Orthopedic Manual Surgical Instrument LXH
    Reamer HTO
    Tray, Surgical, Instrument FSM
    Blade, Scalpel GES
    Caliper KTZ
    Wound Dressing With Animal-Derived Material(S) KGN
    Tap, Bone HWX
    Instrument, Compression HWN
    Tamp HXG
    Halter, Head, Traction HSS
    Driver, Prosthesis HWR
    Screwdriver HXX
    Probe HXB
    Awl HWJ
    Staple, Fixation, Bone JDR
    Bit, Drill HTW

    Proprietary Names

    Screw Depth Measuring Instrument Golden Isles MIS Rod Holder Advantage-LUMBARD Interbody Assembly AOL-07000000 Advantage-LUMBARD Interbody Assembly AOL-00000000 Advantage Lumbar- ALIF, PLIF, DLIF, TLIF Advantage-C Rasp TruTrack Adjustable Drill Guide TruTrack Static Drill Guide 15/18 TruTrack Static Drill Guide 20/25 TruTrack Static Drill Guide 11/13 TruTrack Static Drill Guide 7/9 Golden Isles Pedicle Screw System Advantage-C PEEK Cervical Interbody Fusion Device Impaction Cap Hammerdesis™ Interphalangeal Fusion System Side to Side Double Domino Connector SET SCREW MIS K-wire 45mm screw Standard Driver Reducer MIS Final Tightener shaft Counter Torque Tap Dilator Detachment Instrument Head Body Manipulator Final Tightening Cuff Head Reamer K wire 500mm SS Blunt Threaded TruTrack Inserter Advantage-C Inserter Advantage-C Trial Advantage-LUMBARD Interbody Working Channel Advantage-LUMBARD Interbody Collar Advantage-LUMBARD Interbody Inserter Assembly MIS Counter Torque Distal Advantage-LUMBAR Interbody Dilator MIS Provisional Locking Cap Driver GI MIS Head Turner K wire 500mm SS MIS Cuff Small Tissue Sweeper GI Set Screw Inserted 1/4" QC K wire 500mm Nitinol Blunt Threaded MIS Distractor (lamina spreader style) Sleeve Screw Dilator INSERTER, SET-SCREW, PALM, T30 T25 Short; Egg Handle Convex TLIF DISC SHAVER ADVANTAGE LUMBAR Advantage-LUMBARD Interbody Funnel Rod Indicator MIS Counter Torque Proximal Advantage-LUMBARD Interbody Graft Pusher MIS Tab Breaker K wire 500mm Nitinol Peg Reamer, Small Peg Reamer, Large Hole Reamer, Large Hole Reamer, Small TruTrack Instrument Kit Hammerdesis Interphalangeal Fusion System Advantage-C Advantage-LUMBARD Interbody Implant Caddy AOL-200 Advantage Lumbar Expandable Disc Shaver Rod Measurement Caliper InteliPowder Tap, Double Lead, 4.5mm MIS Compressor Advantage-C Tamp TruTrack Large Staple Punch TruTrack Staple Inserter Advantage-LUMBARD Interbody T30 Shaft Sounder Probe, Curved TruTrack TruTrack MEMORY STAPLE 30X30-2X3MM PKG TruTrack MEMORY STAPLE 20X20-2X3MM PKG TruTrack MEM STAPLE 11X17X15-1.5X1.5MM PKG TruTrack MEMORY STAPLE 7X5-1.5X1.5MM PKG TruTrack MEMORY STAPLE 15X12-1.5X1.5MM PKG TruTrack MEMORY STAPLE 11X8-1.5X1.5MM PKG TruTrack MEM STAPLE 11X19X17-1.5X1.5MM PKG TruTrack MEMORY STAPLE 18X18X15-2X2MM PKG TruTrack MEMORY STAPLE 20X20-2X2MM PKG TruTrack MEMORY STAPLE 15X12-2X2MM PKG TruTrack MEM STAPLE 11X15X13-1.5X1.5MM PKG TruTrack MEMORY STAPLE 9X7-1.5X1.5MM PKG TruTrack MEMORY STAPLE 11X10-1.5X1.5MM PKG TruTrack MEMORY STAPLE 13X10-1.5X1.5MM PKG TruTrack MEM STAPLE 7X5-1.2X1.2MM/XSM PKG TruTrack MEMORY STAPLE 9X7-1.2X1.2MM PKG TruTrack MEMORY STAPLE 7X7-1.5X1.5MM PKG TruTrack MEMORY STAPLE 25X22-2X3MM PKG TruTrack MEMORY STAPLE 9X9-1.5X1.5MM PKG TruTrack MEMORY STAPLE 15X15-1.5X1.5MM PKG TruTrack MEMORY STAPLE 13X15-1.5X1.5MM PKG Advantage-LUMBARD Interbody Disc Drill

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device