BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DEPUY SPINE, INC.

    Reg #: 1526439 · FEI: 1526439 · Expires 2026
    View on FDA
    Products
    108
    Proprietary Names
    257
    Establishment Types
    3
    Classifications
    108

    Registration Details

    Registration Name
    DEPUY SPINE, INC.
    Registration Number
    1526439
    FEI Number
    1526439
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    325 Paramount Drive
    City
    RAYNHAM
    State
    MA
    ZIP
    02767
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171284
    PMA Number
    P960025

    Owner / Operator

    Firm Name
    DePuy Spine, Inc.
    Operator Number
    1526439
    Address
    325 Paramount Drive
    City
    Raynham
    State
    MA
    Postal Code
    02767
    Country
    US
    Correspondent
    Karen Parker

    Products

    Device Name Product Code
    Cannula, Surgical, General & Plastic Surgery GEA
    Filler, Bone Void, Calcium Compound MQV
    Implant, Fixation Device, Spinal JDN
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Clamp HXD
    Orthopedic Stereotaxic Instrument OLO
    Component, Traction, Invasive JEC
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Camera, Surgical And Accessories KQM
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Cement, Bone, Vertebroplasty NDN
    Guide, Needle, Surgical GDF
    Orthopedic Manual Surgical Instrument LXH
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Screw, Fixation, Bone HWC
    Appliance, Fixation, Spinal Interlaminal KWP
    Posterior Cervical Screw System NKG
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Retractor, Self-Retaining, For Neurosurgery GZT
    Mesh, Surgical, Metal EZX
    Trephine HWK
    Screwdriver HXX
    Retractor GAD
    Probe HXB
    Washer, Bolt Nut HTN
    Bone Cement, Posterior Screw Augmentation PML
    Guide, Surgical, Instrument FZX
    Spinal Vertebral Body Replacement Device MQP
    Scissors, Orthopedic, Surgical HRR
    Bone Grafting Material, Synthetic LYC
    Chisel, Surgical, Manual FZO
    Instrument, Compression HWN
    Cerclage, Fixation JDQ
    Hammer, Surgical FZY
    Instrument, Surgical, Non-Powered HAO
    Template HWT
    Elevator HTE
    Neurological Stereotaxic Instrument HAW
    Arthroscope HRX
    Syringe, Piston FMF
    Driver, Surgical, Pin GFC
    Dissector, Surgical, General & Plastic Surgery GDI
    Pliers, Surgical HTC
    Tap, Bone HWX
    Motor, Surgical Instrument, Ac-Powered GEY
    Surgical Table Cushion LWG
    Cutter, Wire HXZ
    Growing Rod System PGM
    Orthosis, Cervical-Thoracic, Rigid IQF
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Curette HTF
    Punch, Femoral Neck HWP
    Awl HWJ
    Goniometer, Nonpowered KQW
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Mixer, Cement, For Clinical Use JDZ
    Plate, Fixation, Bone HRS
    Tong, Skull For Traction HAX
    System, Facet Screw Spinal Device MRW
    Lavage, Jet FQH
    Hook, Surgical, General & Plastic Surgery GDG
    Table, Surgical With Orthopedic Accessories, Manual JEB
    Light, Surgical, Fiberoptic FST
    Bone Cement LOD
    Bender HXW
    Forceps HTD
    Rongeur HTX
    Osteotome, Manual GFI
    Rasp, Surgical, General & Plastic Surgery GAC
    Caliper KTZ
    Extractor HWB
    Osteotome HWM
    Orthosis, Cervical IQK
    Orthosis, Spine, Plate, Laminoplasty, Metal NQW
    Bit, Drill HTW
    Tamp HXG
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Instrument, Manual, Surgical, General Use MDM
    Retainer, Surgical GCZ
    Pin, Fixation, Threaded JDW
    Needle, Suturing, Disposable GAB
    Needle, Aspiration And Injection, Disposable GAA
    Wrench HXC
    Impactor HWA
    Instrument, Cutting, Orthopedic HTZ
    Tray, Surgical, Instrument FSM
    Bone Grafting Material, Animal Source NPM
    Tape, Measuring, Rulers And Calipers FTY
    Neurosurgical Nerve Locator PDQ
    Catheter And Tip, Suction JOL
    Sacroiliac Joint Fixation OUR
    Broach HTQ
    Light, Surgical, Instrument FSQ
    Spinal Pedicle Screw, Fixation, Appliance System MCV
    Appliance, Fixation, Nail/Blade/Plate Combination, Single Component KTW
    Instrument, Bending Or Contouring HXP
    Knife, Orthopedic HTS
    Holder, Needle; Orthopedic HXK
    Driver, Prosthesis HWR
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Operating Room Accessories Table Tray FWZ
    Gauge, Depth HTJ
    Reamer HTO
    Device, Percutaneous, Biopsy MJG

    Proprietary Names

    MONARCH SUMMIT COUGAR EXPEDIUM ISOLA DISCOVERY MOSS VIPER FIBERGRAFT BG Matrix Bone Graft Substitute Moss Miami Moss Moss Miami Magnum Kaneda Ace Halo Vest System University Plate TriALTIS Bremer Halo SPOTLIGHT Expedium Powered Instruments CROSSNAV Navigation Enabled Instruments TELIGEN CART Assembled TELIGEN CART assembled SKYLINE® Anterior Cervical Plate System Confidence Ultra High VSP System CONFIDENCE SPINAL CEMENT SYSTEM BENGAL IN MOTION FRONTIER SLIM-LOC PEAK X-MESH MOUNTAINEER AEGIS JAGUAR BOWTI TiMX PLIF-SG CHARITE I/F CAGE VG2 EAGLE/SWIFT OCELOT KEYSTONE VERTIGRAFT PULSE PIPELINE EAGLE UNIPLATE Emerging Implant Technologies GmBH Instruments TELIGEN EIT Cellular Titanium ALIF Cages EIT Cellular Titanium TLIF Cages EIT Cellular Titanium Cervical Cage EIT Cellular Titanium PLIF Cages SYMPHONY OCT System Uniplate Expedium, Viper, Viper 2 Profile VIPER PRIME Screws with Fenestrations Pipeline Access System PIPELINE II ACCESS SYSTEM Surgical Titanium Mesh Confidence Bone Cement SYMPHONY Open but Unused SCREW REMOVER VSP SKYLINE SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONCORDE T.L.I.F. VIPER PRIME TIMX Kaneda SR TiMX Low Back DEVEX CONCORDE BULLET SPINAL SYSTEM SYMPHONY GRAFT DELIVERY SYSTEM Expedium Spine System Songer Cable VBR Spinal System Summit COUGAR LATERAL CAGE SYSTEM EAGLE PLUS ANTERIOR CERVICAL PLATE SYSTEM VSP ALUMINUM CONTO CrossOver VIPER2 TELIGEN System Navigation Ready Indications Healos Mountaineer OCT Spinal System VELYS™ Active Robotic Assistance KANEDA PLATE DRIVER Viper System Ocelot Stackable Cages M-2 Anterior Plate CONDUIT Instruments SOF'WIRE VIPER Prime, VIPER PRIME Fenestrated, EXPEDIUM Verse Fenestrated Monarch Spine System Symphony Expedium, Synapse Ocelot TriALTIS™ Spine System Bremer Positioning Pad TELIGEN System Navigation Ready Instruments VSP SCREW (END) CUTTER ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS Cellect Graft Preparation Ace Halo Vest System, Bremer Halo System CONDUIT Switch Plate Devex Mesh System EIT Cellular Titanium LLIF Cages ALC Dynamized Expedium VSP SCREW EXTRACTOR SYRINGE CONNECTOR Expedium Spine system Monarch Healos II Bone Graft Substitute X-MESH EXPANDABLE CAGE SYSTEM MOUNTAINEER OCT, SUMMIT SI OCT, SYMPHONY OCT, SUMMIT Fixation System Viper Manual Calibrated Navigation Handle for Use with Brainlab Ace Halo Discovery TELIGEN System Instruments DOC Ventral Cervical Stabilization System ISOLA Pediatric M-2 Plate GPS Advanced; GPS Advanced Cannula Moss Miami Spine System Concorde Bullet Bremer table accessories EXPEDIUM Spine System Bengal Leopard SUMMIT SI OCT Spinal Fixation System UNIPLATE 2 ACP System DOC Ventral Pipeline Universal Navigation Instruments Vertebroplastic Radiopaque Bone Cement EAGLE PLUS MICRO ACP SYSTEM CONDUIT HL LLIF WALLIE-HEINIG OSTEOTOMES Conduit Robotic Integration Instruments DEVEX System COUGAR System CONCORDE System BENGAL System LEOPARD System Viper F2 Facet Fixation System Expedium SFX E-Z Link Summit OCT Concorde System; Pipeline Access System; Mountaineer OCT Spinal System; X-MESH Expandable Cage System ISOLA Spine System; Universal ALIF Instrument Set; Cage Weasel Instruments; Monarch Spine System; Bengal Stackable Cage Expedium Spine System; Viper 2 System; Cougar LS Lateral Interbody Instrument System; Skyline EIT Cellular Titanium Lumbar Cage - T/PLIF Ace Halo Vest System, Bremer Halo system CROSSNAV Disc Preparation and Interbody Instruments FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix B MOUNTAINEER Laminoplasty System Expedium Anterior Expedium Spinal System FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE FIBERGRAFT Aeridyan Matrix Bone Graft Substitute SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM UNIPLATE ACP System E-Z X System VIPER System Spotlight Access System Teligen System Aegis Expedium 4.5 BowTi Expedium Anterior Spine System Driver, Case, Caddy, Lid, Tray or Rod Reducer Expedium SFX Cross Connector System Stabilizer or Bender Moss Miami Spine System Clamp, Compressor, Distractor, or Remover Viper System Post, Tap, Handle or Cap ISOLA Spine System Rod Cutter Expedium Spine System Rod Approximator, Flex. Clipon Reduction device clip, Facilitator or DI Clip-On Reduction Device Viper System Screw Extension, Closed, Tray, Case, Caddy, Lid, Driver, Screwdriver, Tap, Wrench, Tightener or Shaft Moss Miami Magnum Spine System Feeler Monarch Spine System Distractor, Clamp, Compressor, Rocker, Holder, Rod-template or Pusher TLIF SG Instruments Vertebral Spreader Expedium Spine System Bender, Forceps, Cutter, Pan, Alignment Fork, Quick Stick Frame, Modular Clamp or Tap Expedium Spine System Inserter, Probe, Handle, Tap, SI Clip-On Reduction Device Clip Assembly with Pins, Driver orSleeve Expedium Spine System Guide, DI Reduction Tube for Clip-on, Rod Stabilizer, Pedicle Screw Sizer or Pedicle Finder Expedium Spine System Feeler, Wire Cutter, Compressor, Distractor or Pusher Moss Miami Spine System Pusher Expedium Spine System Case, Caddy, Lid, Tray, Laminar Finder, Thoracic Facet Finder, Shaft, Sleeve, Tap or Guide Expedium Spine System Wire Cutter ISOLA Spine System Holder Expedium Spine System Tab Key, Tab remover, Lamina/Transverse Process Starter, Elevator, Rongeur or Gage Expedium SFX Cross Connector System Case, Tray, Lid, Caddy, Name Plate, Handle, Label, Inserter, Shaft or Plate Ruler Monarch Spine System Probe, Handle, Bender, Driver, Screwdriver, Rod Template or Wrench Expedium Spine System Stabilizer, Tab Key, Tab remover, Reduction Clip, Pedicle Finder, Hook Starter or Rotator Expedium Powered Instruments, ELLIPTICAL HANDLE, T-HANDLE, RATCHETING Bengal Stackable Cage System Mountaineer OCT ACROMED EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods CONDUIT Cages; FIBERGRAFT BG Putty Viper 2 KANEDA SPREADER GPS Advanced; 5 cc GPS Advanced Cannula Free Needle Loop HEALOS FX CELLECT BONE MARRO Anterior ISOLA System; Anterior ISOLA Spine System; Kaneda Anterior Scoliosis System; Moss Intradiscal Instruments; Moss Miami Spine System; Concorde System; X-MESH Expandable Cage System TLIF SG Instruments; PLIF SG Instruments; Anterior I/F Cage; Bengal System; VG2 Cervical Instruments; Universal ALIF Instrument Set; Surgical Titanium Mesh; Bengal, Bengal Stackable, Concorde Bullet, Concorde Inline, Cougar, Cougar LS Lateral SWIFT Emerging Implant Technologies GmbH Trays HEALOS Dental CONCORDE Bullet Spinal System Ace Halo Measuring Tape Concorde Inline Spinal System Discovery Bone Screws TELIGEN System Peripheral Motor Nerve Stimulation Indications N/A FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute Peak OCT Spinal Fixation System SIJF Cannulated Screw DePuy Pulse Lumbar Cage System FIBERGRAFT BG Putty Bone Graft Substitute Cougar VIPER Prime Spotlight PL CROSSNAV Navigation Enabled Instruments and Universal Navigation Adaptor Set (UNAS) Jaguar SABER LUMBAR I/F CAGE SYSTEM ADS Bone Nail Monarch 6.35 VSP PLATE BENDER SYMPHONY Navigation Ready Instruments Ace Halo Confidence MOSS MIAMI Spine System Viper2 System Expedium Spine System, Viper System Universal ALIF Instrument Set EIT Cellular Titanium Cages Cougar LS Lateral Cage System Suction Instrument Expedium Fenestrated Screw Systems VIPER Fenestrated Screw Systems CONFIDENCE High Viscosity Spinal Cement Confidence High Viscosity Cement EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) HEALOS Dental Bone Graft Replacement

    Establishment Types

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