BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Precision Spine, Inc.

    Reg #: 3005739886 · FEI: 3005739886 · Expires 2026
    View on FDA
    Products
    48
    Proprietary Names
    43
    Establishment Types
    1
    Classifications
    48

    Registration Details

    Registration Name
    Precision Spine, Inc.
    Registration Number
    3005739886
    FEI Number
    3005739886
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2050 Executive Dr
    City
    Pearl
    State
    MS
    ZIP
    39208
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181606

    Owner / Operator

    Firm Name
    Spinal USA, Inc.
    Operator Number
    9087328
    Address
    2050 Executive Drive, --
    City
    Pearl
    State
    MS
    Postal Code
    39208
    Country
    US
    Correspondent
    Michael C Dawson

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO
    Rongeur HTX
    Hammer, Surgical FZY
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Gauge, Depth HTJ
    Screwdriver HXX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Posterior Cervical Screw System NKG
    Appliance, Fixation, Spinal Interlaminal KWP
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Osteotome HWM
    Awl HWJ
    Orthopedic Manual Surgical Instrument LXH
    Extractor HWB
    Passer, Wire, Orthopedic HXI
    Mallet HXL
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Spinous Process Plate PEK
    Punch, Surgical LRY
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Bone Cement, Posterior Screw Augmentation PML
    Thoracolumbosacral Pedicle Screw System NKB
    System, Facet Screw Spinal Device MRW
    Cutter, Surgical FZT
    Wrench HXC
    Tap, Bone HWX
    Instrument, Compression HWN
    Rasp HTR
    Caliper KTZ
    Tamp HXG
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Probe HXB
    Forceps HTD
    Fork HXE
    Curette HTF
    Chisel, Surgical, Manual FZO
    Elevator HTE
    Template HWT
    Starter, Bone Screw HWD
    Bender HXW
    Guide, Surgical, Instrument FZX
    Retractor GAD
    Prosthesis, Hip, Cement Restrictor JDK
    Impactor HWA
    Instrument, Bending Or Contouring HXP
    Bit, Drill HTW

    Proprietary Names

    PRECISION SPINE NAVIGATION INSTRUMENTATION SHURFIT LUMBAR MD-VUE LATERAL DISCECTOMY SYSTEM ACCUFIT LATERAL PLATE SYSTEM ACCUFIT ALIF PLATE SYSTEM SHURFIT INTERBODY DEVICE SYSTEM DAKOTA ALIF SYSTEM VAULT ALIF SYSTEM VAULT C ACDF SYSTEM SURELOK PSS SYSTEM SURELOK PC SYSTEM SLIMPLICITY ACP SYSTEM REFORM POCT SYSTEM FACET SCREW SYSTEM RCS BUTTRESS PLATE DAKOTA ACDF SYSTEM REFORM PSS SYSTEM ACCUFIT RP SYSTEM MD-VUE LATERAL ACCESS SYSTEM RELI SP SPINOUS PLATING SYSTEM SHURFIT ACIF SYSTEM SHURFIT ACIF 2C SYSTEM FACET SCREW SLIMPLICITY HP ANTERIOR CERVICAL PLATE SYSTEM NEXGEN ANTERIOR CERVICAL PLATE SYSTEM REFORM TI MODULAR DAKOTA LP ACIF SYSTEM SHURFIT 2C LUMBAR SYSTEM VBR System REFORM HA COATED PEDICLE SCREW SYSTEM AccuFit Lateral 2-Hole Plate DAKOTA ALIF REFORM MIDLINE CORTICAL SYSTEM REFORM PEDICLE SCREW SYSTEM SLIMPLICITY SOLO ACP SYSTEM MODIFICATION TO: SURELOK PSS SYSTEM SURELOK PSS SYSTEM - SLC EXTENDED TAB Dakota ALIF System SURELOK PC E-GPS Navigated Instrument System SPINAL USA CEMENT RESTRICTOR S-COMP Reform POCT Navigational Instruments Navigated Instrument System

    Establishment Types

    Manufacture Medical Device