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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)
Show All 72 Submissions
- 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
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Ion 3D
- Page Type
- Cleared 510(K)
- 510(k) Number
- K243265
- 510(k) Type
- Special
- Applicant
- SurGenTec, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/4/2024
- Days to Decision
- 50 days
- Submission Type
- Summary