BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RTI Surgical, Inc. (dba RTI Biologics, Inc.)

    Reg #: 3002719998 · FEI: 3002719998 · Expires 2026
    View on FDA
    Products
    33
    Proprietary Names
    59
    Establishment Types
    3
    Classifications
    33

    Registration Details

    Registration Name
    RTI Surgical, Inc. (dba RTI Biologics, Inc.)
    Registration Number
    3002719998
    FEI Number
    3002719998
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    11621 Research Circle
    City
    ALACHUA
    State
    FL
    ZIP
    32615
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060180

    Owner / Operator

    Firm Name
    RTI Surgical, Inc. (dba RTI Biologics, Inc.)
    Operator Number
    1641375
    Address
    11621 Research Circle
    City
    Alachua
    State
    FL
    Postal Code
    32615
    Country
    US
    Correspondent
    Rosanne Lopez

    Products

    Device Name Product Code
    Tape, Measuring, Rulers And Calipers FTY
    Filler, Bone Void, Calcium Compound MQV
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Clamp HXD
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Cutter, Surgical FZT
    Orthopedic Manual Surgical Instrument LXH
    Mesh, Surgical FTM
    Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed PAJ
    Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery OXH
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
    Bone Grafting Material, Human Source NUN
    Screwdriver HXX
    Rasp HTR
    Staple, Fixation, Bone JDR
    Screw, Fixation, Bone HWC
    Dura Substitute GXQ
    Passer, Wire, Orthopedic HXI
    Brace, Drill HXY
    Osteotome, Manual GFI
    Spatula, Surgical, General & Plastic Surgery GAF
    Reamer HTO
    Bit, Surgical GFG
    Barrier, Animal Source, Intraoral NPL
    Guide, Surgical, Instrument FZX
    Tap, Bone HWX
    Mallet HXL
    Bit, Drill HTW
    Tray, Surgical, Instrument FSM
    Gauge, Depth HTJ
    Syringe, Restorative And Impression Material EID
    Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery OXF
    Tamp HXG

    Proprietary Names

    Caliper component of Precision Allograft Cartilage Kit (PACK) Instrument Set - Ruler, for estimating size component of Fresh OC Instrument Set - Vise component of MAT Instrument Set - Plug Station RapidEase component of Meniscus Allograft Instrument Kit General Instruments component of AlloWedge® Instrument Set Tutomesh® Bovine Pericardium Tutopatch® Bovine Pericardium CANCELLO-PURE® Wedge CopiOs® Cancellous Chips, Cancellous Cubes & Wedge Sterling® Cancellous Chips, Cancellous Cubes, & Wedge Regenavate Regenaform Regenafil AlloSculpt-3D Plus component of Sterling® Interference Screw Instrument Kit Sterling® Interference Screw HT RapidEase Pre-Sutured Tendon Tutopatch DM Graft Tutoplast Bovine Pericardium DM Bovine Pericardium Suturable Dural Graft RTI Allograft Paste ProSpace DBM-D Altiva DBM BioSet® paste Opteform® paste Osteofil® paste Synergent DBM with CCC Sterling® Interference Screw ST component of dbm product accessory kit -Coupling, component of coring station -Carriage break, component of coring station -Base Plate, component of coring station -Coring Reamers -Long pivot arm, component of coring station -Carriage, component of coring station -Short pivot arm, component of coring station -Coring Station, componenet of coring reamer - Surgical Bit Tutodent® membrane CopiOs® Pericardium Membrane - Steinman Pin/K-Wire, used as a guide CANCELLO-PURE® 6MM COTTON BONE WEDGE CANCELLO-PURE® 12MM EVANS BONE WEDGE Synergent DBM Optefil® paste Fortiva¿ porcine dermis, Tutoplast® porcine dermis Precision Allograft Cartilage Kit (PACK™) AlloWedge® Instrument Set Tray Fresh OC Instrument Kit Tray Sterling® Interference Screw Instrument Kit Tray Meniscus Allograft Instrument Kit Tray component of dbm product Fortiva Porcine Dermis

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device