BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Zimmer Trabecular Metal Technology, Inc.

    Reg #: 3005751028 · FEI: 3005751028 · Expires 2026
    View on FDA
    Products
    47
    Proprietary Names
    80
    Establishment Types
    3
    Classifications
    47

    Registration Details

    Registration Name
    Zimmer Trabecular Metal Technology, Inc.
    Registration Number
    3005751028
    FEI Number
    3005751028
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10 POMEROY RD.
    City
    Parsippany
    State
    NJ
    ZIP
    07054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K011904

    Owner / Operator

    Firm Name
    ZIMMER, INC.
    Operator Number
    1822565
    Address
    345 E. Main Street, --
    City
    Warsaw
    State
    IN
    Postal Code
    46580
    Country
    US

    Products

    Device Name Product Code
    Impactor HWA
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Screwdriver HXX
    Spinal Vertebral Body Replacement Device MQP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Caliper KTZ
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Template HWT
    Cutter, Wire HXZ
    Instrument, Compression HWN
    Probe HXB
    Instrument, Cutting, Orthopedic HTZ
    Rongeur HTX
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Gauge, Depth HTJ
    Tamp HXG
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Driver, Prosthesis HWR
    Protractor HTH
    Awl HWJ
    Osteotome HWM
    Wrench HXC
    Extractor HWB
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Orthopedic Manual Surgical Instrument LXH
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Instrument, Bending Or Contouring HXP
    Reamer HTO
    Pusher, Socket HXO
    Brace, Drill HXY
    Positioner, Socket KIL
    Tray, Surgical, Instrument FSM
    Suture, Nonabsorbable GAO
    Plate, Fixation, Bone HRS
    Orthopedic Stereotaxic Instrument OLO
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Guide, Surgical, Instrument FZX
    Broach HTQ
    Bit, Drill HTW
    Countersink HWW
    Rasp HTR
    Retractor GAD
    Knife, Orthopedic HTS

    Proprietary Names

    CERVICAL BONE IMPACTOR BAYONET IMPACTOR HANDLE trabecular metal (tm) vertebral body replacement trabecular metal vertebral body replacement TM Ardis Interbody Fusion Device-Solid TM-400 Lateral Grasping Inserter (Specialty Instrument based off of TM-400 Insert-K120203)- CE Marked for Export Only TM-300 Specialty Inserter (Specialty Instrument based off of TLIF Inserter-K120203)- CE Marked for Export Only TRABECULAR METAL K MUSCULOSKELETAL COMPRESSOR RONGUER STRAIGHT Persona Revision Knee System SCREW DEPTH GAUGE SOFT GRAFT TAMP WIRE TAMP trabecular metal tibial cone augments TM-S Fusion Device and Mergence-S Instrumentation TM-S PLE CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS MODEL XX-YY-ZZZZZZ TM Ardis Inserter EXTRAMEDEDULLARY TI HARRINGTON PROTRACTOR Osteotome BOX OSTEOTOME Ratcheting Deflection Beam Wrench Derotator zimmer tmt trabecular metal vertebral hedrocel trabecular metal vertebral body replacement, mod Vista-S Device CONTINUUM KNEE SYSTEM (CKS) BONE HARVESTER Ultra battery powerd system, accessories, and attachments Battery Powered System, accessories, and attachments PSN Valgus Alignment Guide TM-400 and associated instrumentation hedrocel trabecular metal vertebral body replacement Trabecular Metal Glenoid B/F Comple trabecular metal acetabular augments explant osteonecrosis intervention impl RETRACTOR ZIMMER BRACE Positioner, Socket Universal Sterilization Case RETRACTOR CASE Various Trays LABELING FOR MYO/WIRE II STERNOTOMY SUTURES TRABECULAR METAL OSTEONEC ROSA® Knee System TM Ardis and Accessories trabecular metal tibial and femoral cones CONTINUUM HIP SYSTEM (CHS) Modification to Trabecular Metal Vertebral Body Reconstruct VISTA -S DEVICE modification to trabecular metal femoral Zimmer Segmental System Zimmer Segmental System, Trabecular Metal Stem Collar, 30mm O.D., 00-5852-041-30 Zimmer Segmental System, Trabecular Metal Stem Collar, 30mm O.D., 00-5852-040-30 Zimmer Segmental System, Trabecular Metal Stem Collar, 25mm O.D., 00-5852-040-25 Zimmer Segmental System, Trabecular Metal Stem Collar, 35mm O.D., 00-5852-040-35 Zimmer Segmental System, Trabecular Metal Stem Collar, 35mm O.D., 00-5852-041-35 Vista-S Line Extension TM Coupled Tibial Cones trabecular metal femoral cone augments ROSA Partial Knee System Guide Pin Guide Tube Drill guide FEMORAL STEM BROACH FEMORAL BROACH TIBIAL BROACH L.M.S. SELF-DETACHA COUNTERSINK TAMP COUNTERSINK Rasp Endplate Rasp Nerve Root Retractors BLUNT DISTRACTOR OSTEOTOME

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Manufacture Device in the United States for Export Only