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
- P200022Simplify® Cervical Artificial DiscAPPRPMA Approval
- P170036M6-C Artificial Cervical DiscAPPRPMA Approval
- P120024ACTIVL ARTIFICIAL DISCAPPRPMA Approval
- P090029PRESTIGE LP CERVICAL DISCAPPRPMA Approval
- P110009MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)APPRPMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)APPRPMA Approval
- P100012NUVASIVE PCM CERVICAL DISC SYSTEMAPWDPMA Approval
- P100003SECURE-C ARTIFICIAL CERVICAL DISCAPPRPMA Approval
- P060023BRYAN CERVICAL DISC PROSTHESISAPPRPMA Approval
- P070001PRODISC TM-C TOTAL DISC REPLACEMENTAPPRPMA Approval
- P110002Mobi-C® Cervical Disc Prosthesis One-Level3PMA Approval
- P200022Simplify Cervical Artificial Disc3PMA Approval
- P050010prodisc L3PMA Approval
- P070001prodisc C3PMA Approval
- P110002Mobi-C Cervical Disc Prosthesis One-level3PMA Approval
- P110009Mobi-C Cervical Disc Prosthesis Two-level3PMA Approval
- P200022Simplify Cervical Artificial Disc3PMA Approval
- P110002Mobi-C Cervical Disc Prosthesis One Level3PMA Approval
- P110009Mobi-C Cervical Disc Prosthesis Two Level3PMA Approval
- P090029PRESTIGE LP Cervical Disc3PMA Approval
- P200022Simplify Cervical Artificial Disc3PMA Approval
- P170036M6-C Artificial Cervical Disc3PMA Approval
- P170036M6-C Artificial Cervical Disc3PMA Approval
- P200022Simplify® Cervical Artificial Disc3PMA Approval
- P120024activL Artifical Disc3PMA Approval
- P050010prodisc L Total Disc Replacement3PMA Approval
- P070001prodisc C Total Disc Replacement3PMA Approval
- P110009Mobi-C Cervical Disc Prosthesis (Two-Level Indication)3PMA Approval
- P110002Mobi-C Cervical Disc Prosthesis (One-Level Indication)3PMA Approval
- P090029PRESTIGE LP Cervical Disc3PMA Approval
- P050010prodisc L Total Disc Replacement3PMA Approval
- P060023BRYAN Cervical Disc3PMA Approval
- P090029Prestiege LP Cervical Disc - Two-Level3PMA Approval
- P170036M6-C Artificial Cervical Disc3PMA Approval
- P110002Mobi-C Cervical Disc Prosthesis3PMA Approval
- P110009Mobi-C Cervical Disc Prosthesis3PMA Approval
- P170036M6-C Artificial Cervical Disc3PMA Approval
- P120024Aesculap activL Artificial Disc3PMA Approval
- P050010prodisc L3PMA Approval
- P110002Mobi-C Cervical Disc Prosthesis (one-level indications)3PMA Approval
- P110009Mobi-C Cervical Disc Prosthesis (for Two-Level)3PMA Approval
- P170036M6-C Artificial Cervical Disc3PMA Approval
- P170036M6-C Artificial Cervical Disc3PMA Approval
- P090029Prestige LP Cervical Disc – Two Level3PMA Approval
- P070001prodisc C Total Disc Replacement3PMA Approval
- P120024activeL Artificial Disc3PMA Approval
- P170036M6-C Artificial Cervical Disc3PMA Approval
- P090029Prestige LP Cervical Disc3PMA Approval
- P100012NuVasive PCM Cervical Disc3PMA Approval
- P170036M6-C Artificial Cervical Disc3PMA Approval
- P090029PRESTIGE LP Cervical Disc3PMA Approval
- P120024activL Artificial Disc3PMA Approval
- P110009Mobi-C Cervical Disc Prosthesis3PMA Approval
- P110002Mobi-C Cervical Disc Prosthesis3PMA Approval
- P110009LDR Spine Mobi-C Cervical Disc Prosthesis (Two Level)3PMA Approval
- P110002LDR Spine Mobi-C Cervical Disc Prosthesis (One Level)3PMA Approval
- P090029PRESTIGE LP Cervical Disc3PMA Approval
- P060023BRYAN (TM) CERVICAL DISC3PMA Approval
- P090029PRESTIGE: LP(TM) CERVICAL DISC3PMA Approval
- P050010ProDisc-L Total Disc Replacement3PMA Approval
- P070001ProDisc-C Total Disc Replacement3PMA Approval
- P100003SECURE-C CERVICAL ARTIFICIAL DISC3PMA Approval
- P070001PRODISC-C TOTAL DISC REPLACEMENT3PMA Approval
- P120024ACTIVL ARTIFICIAL DISC3PMA Approval
- P110002MOBI-C Cervical Disc Prosthesis3PMA Approval
- P110009MOBI-C Cervical Disc Prosthesis3PMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)3PMA Approval
- P110009Mobi-C Cervical Disc Prosthesis for use at One or Two Levels3PMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)3PMA Approval
- P110009MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)3PMA Approval
- P120024Aesculap Implant Systems3PMA Approval
- P090029PRESTIGE LP CERVICAL DISC STREAMLINED INSTRUMENTS3PMA Approval
- P110009MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS.3PMA Approval
- P090029PRESTIGE LP CERVICAL DISC3PMA Approval
- P060023BRYAN CERVICAL DISC SYSTEM3PMA Approval
- P090029PRESTIGE LP CERVICAL DISC SYSTEM3PMA Approval
- P060018PRESTIGE CERVICAL DISC SYSTEM3PMA Approval
- P060018PRESTIGE® Cervical Disc3PMA Approval
- P090029PRESTIGE LP(TM) CERVICAL DISC3PMA Approval
- P090029PRESTIGE LP CERVICAL DISC3PMA Approval
- P100003SECURE -C CERVICAL ARTIFICIAL DISC3PMA Approval
- P090029PRESTIGE(R) LP CERVICAL DISC3PMA Approval
- P050010PRODISC-L TOTAL DISC REPLACEMENT3PMA Approval
- P110009THE MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P110002THE MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P110009MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P120024ACTIVL ARTIFICIAL DISC3PMA Approval
- P120024ACTIVL ARTIFICIAL DISC3PMA Approval
- P120024ACTIVL ARTIFICIAL DISC3PMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P110009MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P110009MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P120024ACTIVL ARTIFICIAL DISC3PMA Approval
- P090029PRESTIGE (R) LP CERVICAL DISC3PMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P110009MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)3PMA Approval
- P110009MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)3PMA Approval
- P070001PRODISC -C TOTAL DISC REPLACEMENT3PMA Approval
- P100012NU VASIVE PCM CERVICAL DISC SYSTEM3PMA Approval
- P100003SECURE -C CERVICAL ARTIFICIAL DISC3PMA Approval
- P050010SYNTHES PRODISC-L TOTAL DISC REPLACEMENT3PMA Approval
- P070001SYNTHES PRODISC-C TOTAL DISC REPLACEMENT3PMA Approval
- P050010PRODISC-L3PMA Approval
- P090029PRESTIGE LP CERVICAL DISC3PMA Approval
- P110002LDR SPINE MOBI-C CERVICAL DISC PROTHESIS (ONE LEVEL INDICATION)3PMA Approval
- P110009LDR SPINE MOBI-C CERVICAL DISC PROSTHESIS (TWO LEVEL INDICATION)3PMA Approval
- P110009MOBI-C CERVICAL DISC PROSTHESIS (TWO LEVELS)3PMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS (ONE LEVEL)3PMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P050010SYNTHES PRODISC-L TOTAL DISC REPLACEMENT3PMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P110009MOBI-C CERVICAL DISC PROTHESIS3PMA Approval
- P110009MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P100003SECURE -C CERVICAL ARTIFICIAL DISC3PMA Approval
- P110009MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P100012NUVASIVE PCM CERVICAL DISC SYSTEM3PMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS FOR USE AT ONE OR TWO LEVELS3PMA Approval
- P110009MOBI-C CERVICAL DISC PROSTHESIS FOR USE AT ONE OR TWO LEVELS3PMA Approval
- P110009MOBI-C CERVICAL DISC PROTHESIS3PMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS3PMA Approval
- P100003SECURE-C CERVICAL ARTIFICIAL DISC3PMA Approval
- P110009MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)3PMA Approval
- P110002MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)3PMA Approval
- P060018PRESTIGE CERVICAL DISC3PMA Approval
- P100012NUVASIVE PCM CERVICAL DISC3PMA Approval
- P100012NUVASIVE'S PCM CERVICAL DISC3PMA Approval
- P100012PCM CERVICAL DISC3PMA Approval
- P100003SECURE -C CERVICAL ARTIFICIAL DISC3PMA Approval
- P100012NUVASIVE'S PCM CERVICAL DISC3PMA Approval
- P060023BRYAN CERVICAL DISC3PMA Approval
- P060023BRYAN CERVICAL DISC3PMA Approval
- P100012NUVASIVE PCM CERVICAL DISC SYSTEM3PMA Approval
- P100003SECURE-C ARTIFICIAL CERVICAL DISC3PMA Approval
- P060023BRYAN CERVICAL DISC3PMA Approval
- P050010PRODISC-L TOTAL DISC REPLACEMENT3PMA Approval
- P060023BRYAN CERVICAL DISC3PMA Approval
- P070001PRODISC -C TOTAL DISC REPLACEMENT3PMA Approval
- P050010PRODISC -L TOTAL DISC REPLACEMENT3PMA Approval
- P050010PRODISC - L TOTAL DISC REPLACEMENT3PMA Approval
- P070001PRODISC -C TOTAL DISC REPLACEMENT3PMA Approval
- P060018PRESTIGE CERVICAL DISC3PMA Approval
- P050010PRODISC-L TOTAL DISC REPLACEMENT3PMA Approval
- P050010PRODISC -L TOTAL DISC REPLACEMENT3PMA Approval
- P070001PRODISC -C TOTAL DISC REPLACEMENT3PMA Approval
- P040006IN MOTION LUMBAR ARTIFICIAL DISC3PMA Approval
- P070001PRODISC-C TOTAL DISC REPLACEMENT3PMA Approval
- P050010PRODISC-L TOTAL DISC REPLACEMENT3PMA Approval
- P070001PRODISC C TOTAL DISC REPLACEMENT3PMA Approval
- P070001PRODISC-C TOTAL DISC REPLACEMENT3PMA Approval
- P070001PRODISC-C TOTAL DISC REPLACEMENT3PMA Approval
- P070001PRO-DISC C TOTAL DISC REPLACEMENT3PMA Approval
- P050010PRODISC L TOTAL REPLACEMENT3PMA Approval
- P050010PRODISC L TOTAL DISC REPLACEMENT3PMA Approval
- P060023BRYAN CERVICAL DISC PROSTHESIS3PMA Approval
- P050010PRODISC L TOTAL DISC REPLACEMENT3PMA Approval
- P050010PRODISC L TOTAL DISC REPLACEMENT3PMA Approval
- P070001PRODISC C TOTAL DISC REPLACEMENT3PMA Approval
- P070001PRODISC-C TOTAL DISC REPLACEMENT3PMA Approval
- P050010PRODISC-L TOTAL DISC REPLACEMENT3PMA Approval
- P070001PRODISC TM-C TOTAL DISC REPLACEMENT3PMA Approval
- P060018PRESTIGE CERVICAL DISC3PMA Approval
- P040006IN MOTION ARTIFICIAL DISC3PMA Approval
- P060018PRESTIGE CERVICAL DISC SYSTEM3PMA Approval
- P040006CHARITE ARTIFICIAL DISC3PMA Approval
- P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICE3PMA Approval
- P040006CHARITE ARTIFICIAL DISC3PMA Approval
- P040006CHARITE ARTIFICIAL DISC3PMA Approval
- P040006CHARITE ARTIFICIAL DISC3PMA Approval
- 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
- 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
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PRESTIGE CERVICAL DISC SYSTEM
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- MEDTRONIC SOFAMOR DANEK, INC.
- Trade Name
- PRESTIGE CERVICAL DISC SYSTEM
- Generic Name
- Prosthesis, intervertebral disc
- Decision Date
- 7/16/2007
- Days to Decision
- 423 days
- Decision Code
- APWD
- FDA Decision
- Withdrawal after approval