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- MiscellaneousMiscellaneous
- QHGDefect Measurement Tool2Product Code
- QLQManual Instruments Designed For Use With Total Disc Replacement Devices2Product Code
- QLRManual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices2Product 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
- 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
- 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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Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
- Page Type
- Product Code
- Definition
- A shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials, such as pyrolytic carbon,and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement (§ 888.3027). This device is not intended for use in total shoulder arthroplasty.
- Physical State
- Device made of more than one sub-component, that is, a modular ceramic humeral head which replaces the humeral articular surface, and an intramedullary stem made of metallic alloys, such as titanium or cobalt-chromium-molybdenum to be fixed without bone cement (888.3027).
- Technical Method
- Replaces the articular surface and proximal end of the humerus.
- Target Area
- Shoulder joint, proximal humerus.
- Regulation Medical Specialty
- Orthopedic
- Review Panel
- Orthopedic
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 888.3695
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- Yes
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code QKW is linked to regulation 21CFR888.3695, which does not seem to exist yet. It may be pending at the moment.