Anesthesiology
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- MiscellaneousMiscellaneous
- QHGDefect Measurement Tool2Product Code
- NQOProsthesis, Spinous Process Spacer/Plate3Product Code
- HTMStimulator, Osteogenesis, Electric, Battery-Operated, Invasive3Product Code
- HWFProsthesis, Ligament3Product Code
- LMLLigaments And Tendons, Synthetic3Product Code
- LMNCeramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses3Product Code
- LOEStimulator, Invasive Bone Growth3Product Code
- LOFStimulator, Bone Growth, Non-Invasive3Product Code
- LPFProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented3Product Code
- LPQStimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep3Product Code
- LWAProsthesis, Ligament, Ptfe3Product Code
- LXCMonitor, Pressure, IntracompartmentalUProduct Code
- LXYProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer3Product Code
- LZJProsthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-ConstrainedUProduct Code
- MBDProsthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer3Product Code
- MBJFastener, Fixation, Biodegradable, Hard Tissue3Product Code
- MBSFiller, Bone Void, Non-Osteoinduction3Product Code
- MCVSpinal Pedicle Screw, Fixation, Appliance System3Product Code
- MDIProsthesis, Rib ReplacementUProduct Code
- MJOProsthesis, Intervertebral Disc3Product Code
- MJTProsthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented3Product Code
- MOZAcid, Hyaluronic, Intraarticular3Product Code
- MPKSemi-Constrained Metal/Polymer Finger Joint ProsthesisFProduct Code
- MPWFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction3Product Code
- MQOProsthetic Disc Nucleus DeviceNProduct Code
- MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented3Product Code
- MRWSystem, Facet Screw Spinal DeviceUProduct Code
- K252153FFX Facet Fixation SystemUCleared 510(K)
- K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantUCleared 510(K)
- K250920Arthrex Spine Compression FT ScrewUCleared 510(K)
- K242527The Karma® Fixation SystemUCleared 510(K)
- K243865AERO MIS Facet Fusion SystemUCleared 510(K)
- K243265Ion 3DUCleared 510(K)
- K242650zLOCK Lumbar Facet Fixation SystemUCleared 510(K)
- K241035PMT Posterior Cervical Stabilization System (PCSS)UCleared 510(K)
- K241416Ion 3DUCleared 510(K)
- K232468SC Medica FFXUCleared 510(K)
- K240085zLOCK Lumbar Facet Fixation SystemUCleared 510(K)
- K240086Ion 3DUCleared 510(K)
- K230840PMT Facet Fixation System, Lumbar (PMT FFS-LX)UCleared 510(K)
- K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone SystemUCleared 510(K)
- K230297PMT Expandable Cage (PMT EXP)UCleared 510(K)
- K220951PMT Facet Fixation System (PMT FFS)UCleared 510(K)
- K222515FaSet Fixation SystemUCleared 510(K)
- K211855Ion Facet Screw SystemUCleared 510(K)
- K192744CORRIDOR Fixation SystemUCleared 510(K)
- K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation SystemUCleared 510(K)
- K183589PMT Facet ScrewUCleared 510(K)
- K180729FaSet Fixation SystemUCleared 510(K)
- K173198Facet Screw Fixation SystemUCleared 510(K)
- K163374ALLY™ Facet ScrewsUCleared 510(K)
- K161798FacetBRIDGE® SystemUCleared 510(K)
- K152137FacetBRIDGE SystemUCleared 510(K)
- K150223Facet-Link Stabilization PlatformUCleared 510(K)
- K142980Proficient (TM) Facet Screw Spine SystemUCleared 510(K)
- K132859INTEGRA FACET FIXATION SYSTEMUCleared 510(K)
- K132126SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEMUCleared 510(K)
- K130863FACET SCREW SYSTEMUCleared 510(K)
- K131417FACET FIXXUCleared 510(K)
- K120597KOMPREDAUCleared 510(K)
- K123932ZYGAFIX SPINAL FACET SCREW SYSTEMUCleared 510(K)
- K123497FACET SCREW SYSTEMUCleared 510(K)
- K123218ILLICO FS FACET FIXATION SYSTEMUCleared 510(K)
- K121551RESOLUTE FACET SCREW SYSTEMUCleared 510(K)
- K120340VENUS FACET SCREW SYSTEMUCleared 510(K)
- K121850Typhoon(TM) Facet Screw Fixation SystemUCleared 510(K)
- K113011SPARTAN S3 FACET SYSTEMUCleared 510(K)
- K110170RAPTOR FACET FIXATION SYSTEMUCleared 510(K)
- K112097GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5UCleared 510(K)
- K101762VIPER F2 FACET FIXATION SYSTEMUCleared 510(K)
- K101765KYPHON ANCHOR FACET SCREW SYSTEMUCleared 510(K)
- K102438PRIMALOK FACET FIXATION SYSTEMUCleared 510(K)
- K101364LANX FACET SCREW SYSTEMUCleared 510(K)
- K101284FACET SCREW SYSTEMUCleared 510(K)
- K100154FIXCET SPINAL FACET SCREW SYSTEMUCleared 510(K)
- K092568SPARTAN S3 FACET SYSTEMUCleared 510(K)
- K092464SPINEOLOGY FACET SCREWUCleared 510(K)
- K090952ZYFUSE FACET FIXATION SYSTEMUCleared 510(K)
- K090865LIFE SPINE FACET SCREW SPINAL SYSTEMUCleared 510(K)
- K090767PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZERUCleared 510(K)
- K083442CORRIDOR FIXATION SYSTEMUCleared 510(K)
- K082795SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANTUCleared 510(K)
- K073515TRANS1 FACET SCREWUCleared 510(K)
- K071420CHAMELEON FIXATION SYSTEMUCleared 510(K)
- K062391DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00UCleared 510(K)
- K061041US SPINE FACET FIXATION SYSTEMUCleared 510(K)
- K0520433.8MM CS FACET COMPRESSION DEVICEUCleared 510(K)
- K051856TRANS1 FACET SCREWSUCleared 510(K)
- K0519494.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040UCleared 510(K)
- K0433514.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR NUCleared 510(K)
- K031657STRYKER SPINE OASYS BONE SCREWUCleared 510(K)
- K021705MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEMUCleared 510(K)
- K020411NUVASIVE TRIAD FACET SCREW SYSTEMUCleared 510(K)
- K013829MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEMUCleared 510(K)
- K012773DISCOVERY FACET SCREW FIXATION SYSTEMUCleared 510(K)
- K003928TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEMUCleared 510(K)
- K001323NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREWUCleared 510(K)
- K994308NUVASIVE TOWNLEY FACET SCREWUCleared 510(K)
- K953076TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEMUCleared 510(K)
- NBNGenerator, Shock-Wave, For Pain Relief3Product Code
- NCOImplant, Cartilage, For Articular Cartilage Repair3Product Code
- NEGFinger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis3Product Code
- NEKFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction3Product Code
- NJLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing3Product Code
- NOXFiller, Bone Void, Synthetic Peptide3Product Code
- NRAProsthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing3Product Code
- NTGProsthesis, Ankle, Uncemented, Non-Constrained3Product Code
- NVRIntervertebral Fusion Device With Bone Graft, Solid-Sphere, LumbarUProduct Code
- NXTProsthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing3Product Code
- OJZFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - HdeFProduct Code
- OKDFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone NonunionFProduct Code
- OMEExtracorporeal Shock Wave Treatment3Product Code
- OMXHigh Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger ProsthesisFProduct Code
- OVOProsthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation3Product Code
- OYRFiller, Bone Void, Recombinant Platelet-Derived Growth FactorNProduct Code
- PBUBone Void Filler, SyringeNProduct Code
- PFMHemibridge SystemNProduct Code
- PGMGrowing Rod SystemUProduct Code
- PGNGrowing Rod System- Magnetic ActuationUProduct Code
- PIXElbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented ProsthesisNProduct Code
- PJYOsseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees3Product Code
- PNWProsthesis, Metatarsophalangeal Joint Cartilage Replacement Implant3Product Code
- PWGSpinal Fixation SystemNProduct Code
- QCGFiller, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow LesionsNProduct Code
- QESReherniation Reduction Device3Product Code
- QGPPosterior Ratcheting Rod SystemNProduct Code
- QHPVertebral Body Tethering SystemNProduct Code
- QNNTalus SpacerFProduct Code
- QRRFiller, Bone Void, Calcium Compound Containing Gentamicin2Product Code
- QJDAbsorbable Metallic Bone Fixation Fastener2Product Code
- QKWShoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis2Product Code
- QVVMedial Knee Implanted Shock Absorber2Product Code
- QWLIntraoperative Surgical Angle Measurement Tool2Product Code
- QRUImplant, Resorbable, For Articular Osteochondral Repair3Product Code
- QWKProsthesis, Posterior Spinal Elements3Product Code
- QYQProsthesis, Total Talus Replacement With Soft Tissue Attachment Sites, MetalFProduct Code
- QZOWearable Vibration Device For Orthopedic Use2Product Code
- QZYSpinal Fusion Device With Quaternary Ammonium Compound Coating2Product Code
- QZZLimb And Joint Salvage Device With Coating For Bacteria Reduction2Product Code
- QVLAbsorbable Gel For Intraoperative Use In Spine Surgery2Product Code
- SFAProsthesis, Finger, Semi-Constrained, Metal/Polymer3Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
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- UnknownReview Panel
Ion 3D
- Page Type
- Cleared 510(K)
- 510(k) Number
- K240086
- 510(k) Type
- Special
- Applicant
- SurGenTec, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/8/2024
- Days to Decision
- 28 days
- Submission Type
- Summary