BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EXACTECH, INC.

    Reg #: 1038671 · FEI: 1038671 · Expires 2026
    View on FDA
    Products
    62
    Proprietary Names
    410
    Establishment Types
    5
    Classifications
    62

    Registration Details

    Registration Name
    EXACTECH, INC.
    Registration Number
    1038671
    FEI Number
    1038671
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2320 N.W. 66TH CT.
    City
    GAINESVILLE
    State
    FL
    ZIP
    32653
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102951

    Owner / Operator

    Firm Name
    EXACTECH, INC.
    Operator Number
    1038671
    Address
    2320 NW 66TH CT, --
    City
    Gainesville
    State
    FL
    Postal Code
    32653
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Shoulder Prosthesis, Reverse Configuration PHX
    Template HWT
    Guide, Surgical, Instrument FZX
    Curette, Surgical, General Use FZS
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Screwdriver HXX
    Screw, Fixation, Bone HWC
    Broach HTQ
    Chisel (Osteotome) KDG
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Plate, Fixation, Bone HRS
    Filler, Bone Void, Calcium Compound MQV
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Orthopedic Manual Surgical Instrument LXH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Extractor HWB
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Driver, Prosthesis HWR
    Retractor GAD
    Wrench HXC
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Staple, Fixation, Bone JDR
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Prosthesis, Ankle, Uncemented, Non-Constrained NTG
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Stripper, Surgical HRT
    Impactor HWA
    Tamp HXG
    Bone Grafting Material, Human Source NUN
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Starter, Bone Screw HWD
    Brace, Drill HXY
    Osteotome HWM
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Kit, Surgical Instrument, Disposable KDD
    File HTP
    Bit, Drill HTW
    Gouge, Surgical, General & Plastic Surgery GDH
    Rasp HTR
    Punch, Femoral Neck HWP
    Gauge, Depth HTJ
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing NJL
    Hook, Bone KIK
    Reamer HTO
    Elevator HTE
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Instrument, Compression HWN
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Positioner, Socket KIL
    Instrument, Manual, Surgical, General Use MDM
    Tray, Surgical, Instrument FSM
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY

    Proprietary Names

    Equinoxe Fixed Angle Replicator Plates Equinoxe Cast Glenospheres Equinoxe Cast Humeral Heads TEMPLATE Guide Orthopaedic Bone curette, reusable EXACTECH SURGICAL SCREWDRIVER EPIC BROACH Osteotome TRULIANT® Novation 12/14 Press Fit Femrl Stem Vantage Equinoxe Optecure +CCC KNEE ORTHOPEDIC SURGICAL INSTRUMEN EXACTECH HIP TS Truliant PS Cemented Femoral, size 6 Right Truliant PS Cemented Femoral, size 5 Right Truliant CR Cemented Femoral, size 1 Left Truliant CR Cemented Femoral, size 2.5 Right Truliant PS Cemented Femoral, size 0 Left Truliant PS Cemented Femoral, size 0 Right Truliant CR Cemented Femoral, size 5 Right Truliant CR Cemented Femoral, size 3.5 Left Truliant PS Cemented Femoral, size 1.5 Right Truliant CR Cemented Femoral, size 1.5 Left Truliant CR Cemented Femoral, size 3 Right Truliant PS Cemented Femoral, size 1 Left Truliant CR Cemented Femoral, size 3 Left Truliant Cemented Femoral Component Truliant PS Cemented Femoral, size 3 Left Truliant PS Cemented Femoral, size 3.5 Right Truliant CR Cemented Femoral, size 2.5 Left Truliant CR Cemented Femoral, size 0 Left Truliant PS Cemented Femoral, size 1.5 Left Truliant CR Cemented Femoral, size 1 Right Truliant CR Cemented Femoral, size 4 Left Truliant PS Cemented Femoral, size 2 Left Truliant PS Cemented Femoral, size 4 Left Truliant CR Cemented Femoral, size 2 Left Truliant PS Cemented Femoral, size 4 Right Truliant CR Cemented Femoral, size 0 Right Truliant CR Cemented Femoral, size 5 Left Truliant CR Cemented Femoral, size 2 Right Truliant PS Cemented Femoral, size 1 Right Truliant PS Cemented Femoral, size 5 Left Truliant PS Cemented Femoral, size 2.5 Left Truliant CR Cemented Femoral, size 3.5 Right Truliant PS Cemented Femoral, size 6 Left Truliant PS Cemented Femoral, size 3.5 Left Truliant PS Cemented Femoral, size 2.5 Right Truliant PS Cemented Femoral, size 2 Right Truliant CR Cemented Femoral, size 6 Right Truliant CR Cemented Femoral, size 6 Left Truliant CR Cemented Femoral, size 1.5 Right Truliant PS Cemented Femoral, size 3 Right Truliant CR Cemented Femoral, size 4 Right AcuMatch A-Series Enhnced Polyethyl EXTRACTOR Equinoxe Fracture Plate Optetrak Constrained Condylar Knee Equinoxe Preserve Stem OPTETRAK UNICONDYLAR KNEE FEMORAL STEM DRIVER Novation Element Press-Fit Femoral Stem Novation Element Press Fit Stem Alteon Monobloc Revision Stem Equinoxe Extra Short Humeral Heads Optetrak Proximal Tibial Spacer Equinoxe Stemless Shoulder Exactech Total Hip System Cruciate Retaining Cemented Knee Equinoxe Rev. Shoulder Fracture Hum Orthopaedic implant/instrument dismantling device Novation Crown Cup Equinoxe UHMWPE Posterior Augment Pegged Glenoids Exactech Optetrak Logic CC Knee System AcuMatch M-Series ExSml Metaphyseal Novation InteGrip Acetabular Augments Vantage Mobile Bearing Ankle Femoral Heads and Novation Crown Cup Acetabular Liners Cruciate Retaining Cemented Tibial Exactech Novation XLE Acetabular Liners Exactech AcuMatch XLE Acetabular Liners Orthopaedic Bone file/rasp, manual Novation Element Reduced Offet Press-Fit Femoral Stems Equinoxe Laser Cage Glenoid Equinoxe UHMWPE 16 degree Posterior Augment Pegged Glenoids Postr Stablizd Cementd CoCr UHMWPE EXACTECH IMPACTOR Novation Empire Acetabular Augments with InteGrip Novation Crown Cup and Liners 12/14 Alumina Femoral Head AcuMatch MSeries 12/14 Neck Segment EXACTECH TIBIAL TAMPS Equinoxe Reverse Shoulder System Logic PS Novation Tapered 12/14 Press-Fit Femoral Stem Optecure Dental +CCC Optecure Dental Novation LPI Prime Femoral Stems Alteon® HA Femoral Stems OPTECURE Tibial Bone Removal Screw Equinoxe Reverse Shoulder Superior Augment Glenoid Plate Equinoxe Reverse Shoulder 38mm and 42mm Glensopheres Equinoxe Reverse Shoulder Glenoid Plate Equinoxe Reverse Shoulder Compression Screw Equinoxe Reverse Shoulder Posterior Augment Glenoid Plate BRACE Exactech Equinoxe 12degree Posterior Augment Pegged Glenoid Integrated Hip System Optetrak Logic Femoral Stem Centralizer Optetrak HiFlex Aysm PS Cemnt Fmrl Optetrak HiFlex PS Tibial Insert Orthopaedic osteotome Porous Coated Curciate Retained Fem Vantage Total Ankle System Optetrak Knee offset Tibial Tray Optetrak Logic CRC Tibial Inserts Optetrak Total Knee Sz 0/1 Delta AcuMatch L-Series Unipolar 12/14 Alumina Femoral Heads 36mm Novation Crown Cup Constrained L&R RESORBABLE ROOM TEM ExactechGPS Optetrak Logic Porous Femoral Component Exactech Bipolar Hip Prosthesis Exactech Equinoxe Reverse Shoulder Novation cemented plus femoral stem Cemented Total Knee Sys Tibial Comp AuRa Hip System Cemented Femrl Stem BIT Logic PSC Tibial Insert 12/14 Total Hip System Alteon Bone Screws Bone curette Equinoxe Small Reverse Shoulder Alteon Tapered Wedge Femoral Stem Exactech Equinoxe Shoulder System Intgrtd Hip Sys M-Sers Fmrl Stm Com M-SERIES ROUND OSTEOTOME AcuMatch A-Series /MCS Con Ace Linr Truliant CRC tibial insert, size 5, 12mm Truliant CR Slope + tibial insert, size 5, 10mm Truliant CR Slope ++ tibial insert, size 2, 12mm Truliant CRC tibial insert, size 3, 12mm Truliant CR Slope + tibial insert, size 4.5, 10mm Truliant CR Slope + tibial insert, size 1, 10mm Truliant CRC tibial insert, size 4.5, 19mm Truliant PSC tibial insert, size 6, 10mm Truliant CR Neutral tibial insert, size 5, 14mm Truliant PS tibial insert, size 2.5, 12mm Truliant CR Slope + tibial insert, size 4.5, 13mm Truliant CR Neutral tibial insert, size 0, 10mm Truliant CR Neutral tibial insert, size 1, 14mm Truliant PSC tibial insert, size 4, 10mm Truliant CR Slope + tibial insert, size 4.5, 11mm Truliant CRC tibial insert, size 3.5, 10mm Truliant CR Cemented Femoral, size 4.5 Left Truliant CR Slope ++ tibial insert, size 4, 12mm Truliant CR Slope + tibial insert, size 1.5, 10mm Truliant PSC tibial insert, size 3.5, 14mm Truliant CRC tibial insert, size 3, 10mm Truliant CR Slope ++ tibial insert, size 4.5, 12mm Truliant PS tibial insert, size 4.5, 9mm Truliant PS tibial insert, size 4.5, 19mm Truliant PSC tibial insert, size 2.5, 12mm Truliant CR Slope ++ tibial insert, size 4.5, 11mm Truliant PSC tibial insert, size 3.5, 12mm Truliant PSC tibial insert, size 2, 10mm Truliant CR Neutral tibial insert, size 4, 14mm Truliant CRC tibial insert, size 0, 10mm Truliant CR Slope + tibial insert, size 5, 12mm Truliant PS tibial insert, size 1.5, 14mm Truliant PS Cemented Femoral, size 4.5 Left Truliant CRC tibial insert, size 6, 10mm Truliant Fit tibial tray, cemented, size 4.5F/4.5T Truliant CR Neutral tibial insert, size 4.5, 14mm Truliant CR Slope + tibial insert, size 2, 12mm Truliant PS tibial insert, size 3, 14mm Truliant CRC tibial insert, size 2, 12mm Truliant CRC tibial insert, size 2, 14mm Truliant CR Slope + tibial insert, size 4, 10mm Truliant PS tibial insert, size 3.5, 12mm Truliant CRC tibial insert, size 0, 12mm Truliant PSC tibial insert, size 3, 14mm Truliant CR Slope ++ tibial insert, size 4.5, 10mm Truliant PSC tibial insert, size 4.5, 19mm Truliant CRC tibial insert, size 1.5, 12mm Truliant PSC tibial insert, size 4.5, 14mm Truliant CR Slope ++ tibial insert, size 0, 10mm Truliant PSC tibial insert, size 4.5, 15mm Truliant CR Neutral tibial insert, size 0, 12mm Truliant PSC tibial insert, size 2, 12mm Truliant PS Cemented Femoral, size 4.5 Right Truliant CR Slope ++ tibial insert, size 4, 10mm Truliant CRC tibial insert, size 1.5, 14mm Truliant CR Slope ++ tibial insert, size 2.5, 10mm Truliant CRC tibial insert, size 4.5, 12mm Truliant CR Slope ++ tibial insert, size 5, 12mm Truliant PSC tibial insert, size 5, 14mm Truliant CR Neutral tibial insert, size 4.5, 9mm Truliant CRC tibial insert, size 4, 12mm Truliant CRC tibial insert, size 4.5, 14mm Truliant PSC tibial insert, size 3.5, 10mm Truliant CR Neutral tibial insert, size 6, 14mm Truliant CRC tibial insert, size 4.5, 9mm Truliant CR Neutral tibial insert, size 1.5, 10mm Truliant PS tibial insert, size 0, 14mm Truliant CRC tibial insert, size 2.5, 12mm Truliant CRC tibial insert, size 2, 10mm Truliant CR Slope + tibial insert, size 2, 10mm Truliant CR Slope + tibial insert, size 1, 12mm Truliant CR Neutral tibial insert, size 4, 12mm Truliant CR Slope ++ tibial insert, size 3, 10mm Truliant PS tibial insert, size 0, 12mm Truliant PSC tibial insert, size 0, 10mm Truliant CR Slope + tibial insert, size 1.5, 12mm Truliant CR Neutral tibial insert, size 4.5, 10mm Truliant CR Neutral tibial insert, size 1.5, 12mm Truliant CRC tibial insert, size 2.5, 14mm Truliant CR Neutral tibial insert, size 3.5, 14mm Truliant PS tibial insert, size 3, 10mm Truliant CRC tibial insert, size 6, 12mm Truliant CRC tibial insert, size 0, 14mm Truliant Fit tibial tray, cemented, size 4.5F/5.5T Truliant CR Slope + tibial insert, size 4.5, 9mm Truliant CR Slope ++ tibial insert, size 1.5, 12mm Truliant PSC tibial insert, size 6, 14mm Truliant PSC tibial insert, size 4.5, 9mm Truliant PS tibial insert, size 2, 12mm Truliant CR Neutral tibial insert, size 2, 10mm Truliant CRC tibial insert, size 3.5, 14mm Truliant PS tibial insert, size 3.5, 14mm Truliant CRC tibial insert, size 4.5, 17mm Truliant CR Neutral tibial insert, size 0, 14mm Truliant PS tibial insert, size 6, 12mm Truliant CRC tibial insert, size 2.5, 10mm Truliant PSC tibial insert, size 4.5, 11mm Truliant PS tibial insert, size 0, 10mm Truliant CR Slope + tibial insert, size 4, 12mm Truliant CR Neutral tibial insert, size 5, 10mm Truliant CRC tibial insert, size 4, 10mm Truliant CR Neutral tibial insert, size 3.5, 12mm Truliant CR Neutral tibial insert, size 1, 12mm Truliant CRC tibial insert, size 4.5, 11mm Truliant CR Slope + tibial insert, size 0, 12mm Truliant PS tibial insert, size 2, 14mm Truliant CR Slope ++ tibial insert, size 1, 10mm Truliant PS tibial insert, size 4.5, 15mm Truliant PSC tibial insert, size 5, 10mm Truliant CR Slope ++ tibial insert, size 5, 10mm Truliant CR Neutral tibial insert, size 2, 12mm Truliant CR Slope + tibial insert, size 2.5, 10mm Truliant CRC tibial insert, size 5, 14mm Truliant PS tibial insert, size 5, 10mm Truliant CR Slope ++ tibial insert, size 3.5, 10mm Truliant PSC tibial insert, size 2.5, 14mm Truliant CRC tibial insert, size 5, 10mm Truliant PSC tibial insert, size 3, 12mm Truliant CR Neutral tibial insert, size 2.5, 10mm Truliant CR Neutral tibial insert, size 4.5, 11mm Truliant PS tibial insert, size 2.5, 14mm Truliant CR Slope + tibial insert, size 6, 12mm Truliant CR Neutral tibial insert, size 1.5, 14mm Truliant PS tibial insert, size 4, 14mm Truliant PSC tibial insert, size 1, 10mm Truliant PSC tibial insert, size 1, 12mm Truliant PS tibial insert, size 1.5, 12mm Truliant CRC tibial insert, size 4.5, 13mm Truliant CR Slope + tibial insert, size 4.5, 12mm Truliant PS tibial insert, size 4.5, 14mm Truliant PSC tibial insert, size 4.5, 17mm Truliant CR Neutral tibial insert, size 2.5, 14mm Truliant PS tibial insert, size 4.5, 11mm Truliant CR Slope ++ tibial insert, size 2, 10mm Truliant PSC tibial insert, size 4.5, 13mm Truliant PSC tibial insert, size 0, 14mm Truliant CR Slope + tibial insert, size 3, 12mm Truliant CRC tibial insert, size 3.5, 12mm Truliant PS tibial insert, size 1, 14mm Truliant PSC tibial insert, size 3, 10mm Truliant CR Slope + tibial insert, size 2.5, 12mm Truliant PS tibial insert, size 2.5, 10mm Truliant CR Neutral tibial insert, size 2.5, 12mm Truliant CRC tibial insert, size 4, 14mm Truliant CRC tibial insert, size 4.5, 10mm Truliant CRC tibial insert, size 1.5, 10mm Truliant CRC tibial insert, size 3, 14mm Truliant PS tibial insert, size 5, 12mm Truliant CR Neutral tibial insert, size 4.5, 15mm Truliant CR Neutral tibial insert, size 4.5, 17mm Truliant CR Neutral tibial insert, size 4, 10mm Truliant CRC tibial insert, size 1, 10mm Truliant PS tibial insert, size 1, 10mm Truliant PSC tibial insert, size 4, 12mm Truliant PS tibial insert, size 6, 14mm Truliant CR Neutral tibial insert, size 3, 14mm Truliant CR Neutral tibial insert, size 1, 10mm Truliant CR Neutral tibial insert, size 3, 10mm Truliant PSC tibial insert, size 5, 12mm Truliant CR Neutral tibial insert, size 4.5, 12mm Truliant Fit tibial tray, cemented, size 4.5F/3.5T Truliant CR Slope ++ tibial insert, size 3, 12mm Truliant CR Slope + tibial insert, size 3.5, 12mm Truliant PSC tibial insert, size 1, 14mm Truliant PS tibial insert, size 6, 10mm Truliant CR Slope ++ tibial insert, size 0, 12mm Truliant PS tibial insert, size 1, 12mm Truliant CR Neutral tibial insert, size 3, 12mm Truliant PS tibial insert, size 4, 10mm Truliant CR Slope + tibial insert, size 3.5, 10mm Truliant CR Neutral tibial insert, size 4.5, 13mm Truliant PSC tibial insert, size 4.5, 12mm Truliant CR Slope ++ tibial insert, size 4.5, 9mm Truliant PSC tibial insert, size 2, 14mm Truliant PS tibial insert, size 4.5, 13mm Truliant CR Slope ++ tibial insert, size 1, 12mm Truliant CRC tibial insert, size 4.5, 15mm Truliant CR Slope ++ tibial insert, size 6, 12mm Truliant CR Slope ++ tibial insert, size 1.5, 10mm Truliant PSC tibial insert, size 2.5, 10mm Truliant PS tibial insert, size 3, 12mm Truliant CR Slope + tibial insert, size 3, 10mm Truliant PSC tibial insert, size 4, 14mm Truliant PSC tibial insert, size 1.5, 10mm Truliant PS tibial insert, size 5, 14mm Truliant PS tibial insert, size 4.5, 17mm Truliant PS tibial insert, size 4, 12mm Truliant CRC tibial insert, size 6, 14mm Truliant PSC tibial insert, size 6, 12mm Truliant PSC tibial insert, size 1.5, 12mm Truliant PS tibial insert, size 4.5, 12mm Truliant PS tibial insert, size 4.5, 10mm Truliant CR Neutral tibial insert, size 3.5, 10mm Truliant CR Slope ++ tibial insert, size 2.5, 12mm Truliant CR Neutral tibial insert, size 5, 12mm Truliant CR Slope ++ tibial insert, size 3.5, 12mm Truliant CR Neutral tibial insert, size 6, 10mm Truliant CR Slope + tibial insert, size 0, 10mm Truliant CR Neutral tibial insert, size 2, 14mm Truliant PSC tibial insert, size 0, 12mm Truliant PSC tibial insert, size 4.5, 10mm Truliant CR Cemented Femoral, size 4.5 Right Truliant CR Slope ++ tibial insert, size 4.5, 13mm Truliant PS tibial insert, size 1.5, 10mm Truliant CRC tibial insert, size 1, 14mm Truliant CRC tibial insert, size 1, 12mm Truliant PSC tibial insert, size 1.5, 14mm Truliant CR Neutral tibial insert, size 6, 12mm Truliant PS tibial insert, size 2, 10mm Truliant PS tibial insert, size 3.5, 10mm Alteon Alteon Neck Preserving Femoral Stem DEPTH Optetrak Logic CR Equinoxe Reverse +15mm Adapter Tray Novation Splined RDD Femoral Stems Optecure+CCC Optecure Optetrak Total Knee System Optetrak Logic Porous Femoral Components AcuMatch MSeries LPB 12/14 Femoral Exactech Optetrak Logic Metaphyseal Cones TRULIANT Porous Tibial Tray Ziramic Zirconia 12/14 Femoral Head Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies AcuMatch MSeries Offset Neck Sgmnts Optetrak Logic Fit Tray Optetrak Logic Combo Tibial Tray AcuMatch 12/14 Press-Fit Femrl Stem Optetrak RBK Optetrak Logic RBK Equinoxe Platform Fracture Stem Chrome Cobalt Ball Head Optetrak Logic CR Knee System Equinoxe Cage Glenoid Bone Hook Optecure and Optecure +CCC Exactech Equinoxe Resurfacing Humeral Head System REAMER Exactech Equinoxe Short Replicator Plates Orthopaedic Hand-held retractor Exactech Bone Screws Surgical power tool Optetrak 9mm CR Tibial Insert Slope Prous Coate Postr Stablizd Fmrl Com Novation 12/14 Cemented Femrl Stems AcuMacth 12/14 Cemented Femrl Stems EXACTECH STERILE MODULAR DRILL BITS EXACTECH IMPLANT ASSEMBLER PLIERS AcuMatch L-Series Bipolar Biolox Option Biolox Delta Equinoxe Humeral Reconstruction Prosthesis Alteon Highly Polished Femoral Stem Ziramic Zirconia 12/14 femoral Head EXACTECH ACETABULAR LINER INSERTER Exactech Truliant Porous Femur Advanced Patella Alteon HA Femoral Stem Instrument Tray Equinoxe Shoulder System Novation CFS Press-Fit Stems Novation CFS Cemented Stems Truliant

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only