Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
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- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- NDHNail, Fixation, Bone, Metallic2Product Code
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HRZProsthesis, Knee, Hinged (Metal-Metal)3Product Code
- HSAProsthesis, Knee, Hemi-, Femoral3Product Code
- HSBRod, Fixation, Intramedullary And Accessories2Product Code
- NDIStaple, Fixation, Bone, Metallic2Product Code
- HRSPlate, Fixation, Bone2Product Code
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2Product Code
- HSHProsthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)2Product Code
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer2Product Code
- HTGProsthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented2Product Code
- HTNWasher, Bolt Nut2Product Code
- HTYPin, Fixation, Smooth2Product Code
- HWCScrew, Fixation, Bone2Product Code
- HXAProsthesis, Tendon, Passive2Product Code
- JDBProsthesis, Elbow, Semi-Constrained, Cemented2Product Code
- JDCProsthesis, Elbow, Constrained, Cemented2Product Code
- JDDProsthesis, Upper Femoral2Product Code
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal2Product Code
- JDHProsthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal3Product Code
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2Product Code
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)3Product Code
- JDNImplant, Fixation Device, Spinal2Product Code
- JDODevice, Fixation, Proximal Femoral, Implant2Product Code
- JDPCondylar Plate Fixation Implant2Product Code
- JDQCerclage, Fixation2Product Code
- JDRStaple, Fixation, Bone2Product Code
- JDSNail, Fixation, Bone2Product Code
- JDTCap, Bone1Product Code
- JDWPin, Fixation, Threaded2Product Code
- JECComponent, Traction, Invasive2Product Code
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- JWIProsthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained2Product Code
- JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained2Product Code
- KIGProsthesis, Wrist, Constrained, Polymer2Product Code
- KMBProsthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented2Product Code
- KMCProsthesis, Hip, Semi-Constrained, Composite/Metal2Product Code
- KMDProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KRNMetal Cemented Constrained Femorotibial Knee Prosthesis3Product Code
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2Product Code
- KRPProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal3Product Code
- KRQProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- KRSProsthesis, Knee, Hemi-, Femoral (Uncemented)3Product Code
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2Product Code
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component2Product Code
- KTXProsthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented2Product Code
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)3Product Code
- KWBProsthesis, Hip, Hemi-, Acetabular, Cemented, Metal3Product Code
- KWDProsthesis, Toe, Hemi-, Phalangeal2Product Code
- KWEProsthesis, Finger, Constrained, Metal, Uncemented3Product Code
- KWFProsthesis, Finger, Polymer2Product Code
- KWGProsthesis, Finger, Constrained, Metal/Polymer3Product Code
- KWHProsthesis, Toe, Constrained, Polymer2Product Code
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer2Product Code
- KWJProsthesis, Elbow, Hemi-, Humeral, Metal3Product Code
- KWKAppliance, Nail/Blade/Plate Combination, Single Component2Product Code
- KWLProsthesis, Hip, Hemi-, Femoral, Metal2Product Code
- KWMProsthesis, Wrist, Semi-Constrained2Product Code
- KWNProsthesis, Wrist, Carpal Lunate2Product Code
- KWOProsthesis, Wrist, Carpal Scaphoid2Product Code
- KWPAppliance, Fixation, Spinal Interlaminal2Product Code
- KWQAppliance, Fixation, Spinal Intervertebral Body2Product Code
- KWRProsthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented3Product Code
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2Product Code
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2Product Code
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2Product Code
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2Product Code
- KXAProsthesis, Hip, Femoral, Resurfacing2Product Code
- KXBProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer3Product Code
- KXCProsthesis, Ankle, Cemented, Non-Constrained3Product Code
- KXDProsthesis, Hip, Constrained, Metal3Product Code
- KXEProsthesis, Wrist, Hemi-, Ulnar2Product Code
- KYIProsthesis, Wrist, Carpal Trapezium2Product Code
- KYJProsthesis, Finger, Constrained, Polymer2Product Code
- KYKProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KYMMetallic Cemented Glenoid Hemi-Shoulder Prosthesis3Product Code
- KYNProsthesis, Wrist, Constrained, Metal3Product Code
- LBCProsthesis, Finger, Constrained, Metal, Cemented3Product Code
- LGEProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing2Product Code
- LODBone Cement2Product Code
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2Product Code
- LRNWire, Surgical2Product Code
- LTOSpacer, Cement3Product Code
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite2Product Code
- LYPAccessories, Fixation, Spinal Interlaminal2Product Code
- LYTFixation Accessory2Product Code
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2Product Code
- LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball2Product Code
- MAIFastener, Fixation, Biodegradable, Soft Tissue2Product Code
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar2Product Code
- MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish2Product Code
- MBBBone Cement, Antibiotic2Product Code
- MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer2Product Code
- MBIFastener, Fixation, Nondegradable, Soft Tissue2Product Code
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous2Product Code
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)2Product Code
- MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer2Product Code
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate2Product Code
- MJWProsthesis, Subtalar, Plug, Polymer2Product Code
- MNHOrthosis, Spondylolisthesis Spinal Fixation2Product Code
- K162066Reliance Spinal Screw System2Cleared 510(K)
- K162801CastleLoc Spinal Fixation System2Cleared 510(K)
- K162143FixxSure® X-Link2Cleared 510(K)
- K161151Spinal fixation system2Cleared 510(K)
- K162189ANAX™ 5.5 Spinal System2Cleared 510(K)
- K151362HC Spinal System2Cleared 510(K)
- K153404Zavation Spinal System2Cleared 510(K)
- K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System2Cleared 510(K)
- K143013Spinal Inner Fixation System2Cleared 510(K)
- K151695Romeo posterior osteosynthesis system2Cleared 510(K)
- K151116CapLOX II/TowerLOX Pedicle Screw System2Cleared 510(K)
- K150283Republic Spine Dark Star Spinal System2Cleared 510(K)
- K142798PASS LP Spinal System2Cleared 510(K)
- K143417ANAX 5.5 Spinal System2Cleared 510(K)
- K143377PedFuse Pedicle Screw System2Cleared 510(K)
- K142957Ideal pedicle screw spinal system2Cleared 510(K)
- K142655CB PROT II Posterior Spinal System2Cleared 510(K)
- K140359MAXIMIS SPINAL FIXATION SYSTEM2Cleared 510(K)
- K142290KangLi pedical screw spinal system2Cleared 510(K)
- K134011GENERAL SPINAL SYSTEM2Cleared 510(K)
- K133575SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM2Cleared 510(K)
- K141376INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS2Cleared 510(K)
- K140053KANGLI PEDICLE SCREW SPINAL SYSTEM2Cleared 510(K)
- K140678COSMOLOCK PEDICLE SCREW SYSTEM2Cleared 510(K)
- K140787PLS (POSTERIOR LUMBAR SYSTEM)2Cleared 510(K)
- K140948ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K133153SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM2Cleared 510(K)
- K133690TRUE SPINAL FUSSION SYSTEM2Cleared 510(K)
- K133287PRESSON SPINAL FIXATION SYSTEM2Cleared 510(K)
- K132403ANNEXTM ADJACENT LEVEL SYSTEM2Cleared 510(K)
- K132218PERFIX ILIAC SCREW SYSTEM2Cleared 510(K)
- K132101ANAX 5.5 SPINAL SYSTEM2Cleared 510(K)
- K131810OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM2Cleared 510(K)
- K131538CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM2Cleared 510(K)
- K130267ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K122994INTRAMEDULLARY NAIL SYSTEM2Cleared 510(K)
- K123487GSO GS1 CANNULATED SCREW SYSTEM2Cleared 510(K)
- K123164SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM2Cleared 510(K)
- K123476MEGA 5.5 SPINE SYSTEM2Cleared 510(K)
- K122592INSTINCT JAVA SYSTEM2Cleared 510(K)
- K122814GALLEON PEDICLE SCREW SYSTEM2Cleared 510(K)
- K120832FORTEX PEDICLE SCREW SYSTEM2Cleared 510(K)
- K121016RANGE SPINAL SYSTEM (MESA AND DENALI)2Cleared 510(K)
- K120760LDR SPINE SPINETUNE TL SPINAL SYSTEM2Cleared 510(K)
- K111940S 100 PEDICLE SCREW SYSTEM2Cleared 510(K)
- K120491DSS STABILIZATION SYSTEM-RIGID2Cleared 510(K)
- K120353SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM2Cleared 510(K)
- K103573ARTS2 SPINAL FIXATION SYSTEM2Cleared 510(K)
- K110633LANCER PEDICLE SCREW SYSTEM2Cleared 510(K)
- K111995XINGTM SPINE SYSTEM2Cleared 510(K)
- K111690DEVINE SPINAL SYSTEM2Cleared 510(K)
- K110497PASS LP SPINAL SYSTEM2Cleared 510(K)
- K111370ODALYS PEDICLE SCREW SYSTEM2Cleared 510(K)
- K111362REXIOUS SPINAL FIXATION SYSTEM2Cleared 510(K)
- K1024584CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM2Cleared 510(K)
- K110321TIGER SPINE SYSTEM2Cleared 510(K)
- K101374AAXTER A3 POSTERIOR SPINAL SYSTEM2Cleared 510(K)
- K102574PALLA M SPINAL SYSTEM2Cleared 510(K)
- K102636ZENITH PEDICLE SYSTEM2Cleared 510(K)
- K1018184CIS VANE SPINE SYSTEM2Cleared 510(K)
- K103085VENUS BASIC SPINAL FIXATION SYSTEM2Cleared 510(K)
- K102853FLAMENCO SPINAL FIXATION SYSTEM2Cleared 510(K)
- K102870EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM2Cleared 510(K)
- K101446EMERALD SPINAL SYSTEM2Cleared 510(K)
- K101278INERTIA PEDICLE SCREW SYSTEM2Cleared 510(K)
- K102488APEX SPINE SYSTEM W/ COCR RODS2Cleared 510(K)
- K093771QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM2Cleared 510(K)
- K101678ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K100706VENUS BASIC SPINAL FIXATION SYSTEM2Cleared 510(K)
- K100956SPONDY SPINAL FIXATION SYSTEM2Cleared 510(K)
- K100373TYCHE PEDICLE SCREW SYSTEM2Cleared 510(K)
- K100605MIS SYSTEM2Cleared 510(K)
- K093670MODIFICATION TO: OASYS SYSTEM2Cleared 510(K)
- K100122MODIFICATION TO CAPSURE PS SYSTEM2Cleared 510(K)
- K091725PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)2Cleared 510(K)
- K092011NORM SPINAL SYSTEM2Cleared 510(K)
- K083077ULC SPINAL PEDICLE SCREW SYSTEM2Cleared 510(K)
- K083567GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW2Cleared 510(K)
- K090224FORTEX PEDICLE SCREW SYSTEM2Cleared 510(K)
- K090477ALPINE PEDICLE SCREW SYSTEM2Cleared 510(K)
- K091110SPINAL EDGE TITAN PEDICLE SCREW SYSTEM2Cleared 510(K)
- K090424DVX SPINE SYSTEM2Cleared 510(K)
- K090228ROC LUMBAR PLATING SYSTEM2Cleared 510(K)
- K083581LANX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K080611MESA SPINAL SYSTEM2Cleared 510(K)
- K081153NOVEL SPINAL SYSTEM2Cleared 510(K)
- K083826LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM2Cleared 510(K)
- K081165ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K082509EOS SPINAL SYSTEM2Cleared 510(K)
- K082577PASS LP SPINAL SYSTEM2Cleared 510(K)
- K081883MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM2Cleared 510(K)
- K0824534CIS SOLAR AND APOLLON SPINE SYSTEMS2Cleared 510(K)
- K081331FIXXSURE CROSS LINK2Cleared 510(K)
- K081631SINTEA BIOTECH PLS MULTI-AXIAL SCREWS2Cleared 510(K)
- K081041GPS, G SURGICAL PEDICLE SYSTEM2Cleared 510(K)
- K080828MOUNTAINEER OCT SPINAL SYSTEM2Cleared 510(K)
- K081381RANGE SPINAL SYSTEM, LARGE DENALI SCREWS2Cleared 510(K)
- K081296PREFERENCE PEDICLE SCREW SYSTEM2Cleared 510(K)
- K080876DVX SPINE SYSTEM2Cleared 510(K)
- K073531ACCIN PEDICLE SCREW SYSTEM2Cleared 510(K)
- K071890ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM2Cleared 510(K)
- K070530MODIFICATION TO PASSMED SPINAL SYSTEM2Cleared 510(K)
- K072282CAPLESS LI PEDICLE SCREW SYSTEM2Cleared 510(K)
- K070933LOWTOP PEDICLE SCREW SYSTEM2Cleared 510(K)
- K062670VERTIFLEX SPINAL SCREW SYSTEM2Cleared 510(K)
- K062174MODIFICATION TO EXPEDIUM SPINE SYSTEM2Cleared 510(K)
- K061524ISS INTEGRATED SPINE SYSTEM2Cleared 510(K)
- K061813MANTIS SPINAL SYSTEM2Cleared 510(K)
- K061577OVALTWIST PEDICLE SCREW SYSTEM2Cleared 510(K)
- K062196SFX SNAP-FIT CROSS CONNECTOR2Cleared 510(K)
- K061364PILOT POSTERIOR LUMBAR PLATING SYSTEM2Cleared 510(K)
- K062317MODIFICATION TO NUVASIVE SPHERX II SYSTEM2Cleared 510(K)
- K061162BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 20202Cleared 510(K)
- K061915CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K061441EBI 5.5 HELICAL FLANGE SPINAL SYSTEM2Cleared 510(K)
- K061778NUVASIVE SPHERX II SYSTEM2Cleared 510(K)
- K053623NFIX FUSION SYSTEM2Cleared 510(K)
- K061321ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX2Cleared 510(K)
- K0607024CIS VANE SPINE SYSTEM2Cleared 510(K)
- K060118SSP PEDICLE SCREW SYSTEM2Cleared 510(K)
- K060225NUVASIVE SPHERX SYSTEM2Cleared 510(K)
- K053573GSS PEDICLE SCREW SYSTEM2Cleared 510(K)
- K053070CONTOUR II SPINAL SYSTEM2Cleared 510(K)
- K051089GII SPINAL FIXATION SYSTEM2Cleared 510(K)
- K051959NV CORMED SOLAS SPINAL SYSTEM2Cleared 510(K)
- K051044ARCTEC SEMIRIGID PLATING SYSTEM2Cleared 510(K)
- K051697SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM2Cleared 510(K)
- K050461XIA 4.5 SPINAL SYSTEM2Cleared 510(K)
- K051216HYDRALOK SYSTEM2Cleared 510(K)
- K051286ZODIAC SPINAL FIXATION SYSTEM2Cleared 510(K)
- K0504714CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM2Cleared 510(K)
- K043578THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM2Cleared 510(K)
- K043180STRYKER SPINE TRIO PS2Cleared 510(K)
- K050078ROC LUMBAR PLATING SYSTEM2Cleared 510(K)
- K042928MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM2Cleared 510(K)
- K043152VERTEBRON PSS PEDICLE SCREW SYSTEM2Cleared 510(K)
- K043343MODIFICATION TO: CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K043001MX POLYAXIAL PEDICLE SCREW2Cleared 510(K)
- K042640UNI-THREAD SPINAL SYSTEM2Cleared 510(K)
- K042964MX MONOAXIAL PEDICLE SCREW2Cleared 510(K)
- K040747ALADYN RIGID SPINE PLATE2Cleared 510(K)
- K033512PROCYON SPINAL SYSTEM2Cleared 510(K)
- K040442PROTEX STABILIZATION SYSTEM2Cleared 510(K)
- K034056MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K033546NUVASIVE SPINAL SYSTEM2Cleared 510(K)
- K040072MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K032604GII SPINAL FIXATION SYSTEM2Cleared 510(K)
- K033322MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K032855STRYKER SPINE MAPS SYSTEM2Cleared 510(K)
- K031265SHIRAZ-JAVA SPINAL FIXATION SYSTEM2Cleared 510(K)
- K031585U&I, OPTIMA, SPINAL SYSTEM2Cleared 510(K)
- K031423EBI P148 SPINAL FIXATION SYSTEM2Cleared 510(K)
- K023378ORIA CLARIS2Cleared 510(K)
- K030581BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)2Cleared 510(K)
- K031290MODIFICATION TO EASYS TRANSVERSE CONNECTION2Cleared 510(K)
- K030383MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS2Cleared 510(K)
- K023994ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ2Cleared 510(K)
- K024348MONARCH SPINE SYSTEM2Cleared 510(K)
- K020085SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X2Cleared 510(K)
- K023438MODIFICATION TO MONARCH SPINE SYSTEM2Cleared 510(K)
- K023204MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM2Cleared 510(K)
- K021623UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS2Cleared 510(K)
- K021881ENDIUS TITLE SPINAL FIXATION SYSTEM2Cleared 510(K)
- K020356ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM2Cleared 510(K)
- K020247COLORADO 2 SPINAL SYSTEM2Cleared 510(K)
- K021335MONARCH SPINE SYSTEM2Cleared 510(K)
- K021879CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)2Cleared 510(K)
- K021880CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM)2Cleared 510(K)
- K013962EQUATION FIXATION SYSTEM2Cleared 510(K)
- K020699TSRH SPINAL SYSTEM2Cleared 510(K)
- K021148MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD2Cleared 510(K)
- K020681EBI OMEGA21 SPINAL FIXATION SYSTEM2Cleared 510(K)
- K020674BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW2Cleared 510(K)
- K014302UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM2Cleared 510(K)
- K020196MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM2Cleared 510(K)
- K020293OSTEONICS SPINAL SYSTEM2Cleared 510(K)
- K013887BACFIX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K020245MODIFICATION TO ISOBAR SPINAL SYSTEM2Cleared 510(K)
- K014229MODIFICATION TO OPUS SPINAL SYSTEM2Cleared 510(K)
- K014137MODIFICATION TO EBI OMEGA 21 SYSTEM2Cleared 510(K)
- K014076MODIFICATION TO TSRH SPINAL SYSTEM2Cleared 510(K)
- K013688MODIFICATION TO XIA SPINAL SYSTEM2Cleared 510(K)
- K013444ISOBAR SPINAL SYSTEM2Cleared 510(K)
- K013295TIMX SPINAL SYSTEMS2Cleared 510(K)
- K013296MOSS MIAMI SPINAL SYSTEMS2Cleared 510(K)
- K013294MONARCH SPINAL SYSTEMS2Cleared 510(K)
- K012971ISOLA SPINAL SYSTEMS2Cleared 510(K)
- K012273SPIRAL RADIUS 90-D SST SYSTEM2Cleared 510(K)
- K012027MODIFICATION TO XIA SPINE SYSTEM2Cleared 510(K)
- K003733SCS CLOSED SCREW2Cleared 510(K)
- K011182MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS2Cleared 510(K)
- K010369CLARIS PLATE SYSTEM2Cleared 510(K)
- K010845MODIFICATION TO OSTEONICS SPINAL SYSTEM2Cleared 510(K)
- K010742MOSS MIAMI 5.5MM TITANIUM PIN NUT2Cleared 510(K)
- K010720TSRH SPINAL SYSTEM2Cleared 510(K)
- K003463SOCON SPINAL SYSTEM2Cleared 510(K)
- K010776TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS2Cleared 510(K)
- K010535TRIFIX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K010249CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K003764MODIFICATION TO EBI SPINELINK SYSTEM2Cleared 510(K)
- K000641CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K003490OPUS ROD FIXATION SYSTEM2Cleared 510(K)
- K003384VERSALINK TITANIUM ROD-TO-ROD COUPLERS2Cleared 510(K)
- K001044ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM2Cleared 510(K)
- K001668GLOBAL SPINAL FIXATION SYSTEM2Cleared 510(K)
- K002399MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K001255CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K001066CD HORIZON ECLIPSE2Cleared 510(K)
- K001627TRIFIX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K001319XIA SPINE SYSTEM HOOKS2Cleared 510(K)
- K001024PASS SPINAL SYSTEM2Cleared 510(K)
- K991031COLORADO II SPINAL SYSTEM2Cleared 510(K)
- K993503HAIDER-UCR SPINAL SYSTEM2Cleared 510(K)
- K9942885.0MM SPINAL SCREWS2Cleared 510(K)
- K984360COLORADO II SPINAL SYSTEM2Cleared 510(K)
- K000476MODIFICATION TO CD SPINAL SYSTEM2Cleared 510(K)
- K000453MODIFICATION TO CD SPINAL SYSTEM2Cleared 510(K)
- K994217BLACKSTONE SPINAL FIXATION SYSTEM2Cleared 510(K)
- K000094MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K992739CLICK'X2Cleared 510(K)
- K000020MODIFICATION TO ISOBAR SPINAL SYSTEM2Cleared 510(K)
- K993810CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K993551SOCON SPINAL SYSTEM2Cleared 510(K)
- K993926OMNIAXIAL CONNECTOR2Cleared 510(K)
- K993808SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,22202Cleared 510(K)
- K991036DANEK PLATE AND SCREW SYSTEM2Cleared 510(K)
- K991055OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM2Cleared 510(K)
- K991552SYNTHES PEDIATRIC ROD SYSTEM2Cleared 510(K)
- K991528MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR2Cleared 510(K)
- K990721ISOLOCK SPINAL SYSTEM2Cleared 510(K)
- K991460MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM2Cleared 510(K)
- K991364MODIFICATION TO TENOR SPINAL SYSTEM-PLATES2Cleared 510(K)
- K990657TRIFIX PEDICLE SPINAL SCREW ASSEMBLY2Cleared 510(K)
- K990118ISOBAR SPINAL SYSTEM2Cleared 510(K)
- K984302OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS2Cleared 510(K)
- K983152OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS2Cleared 510(K)
- K980761SYNTHES SPINE PEDIATRIC ROD SYSTEM2Cleared 510(K)
- K981714TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM2Cleared 510(K)
- K981113PEDIATRIC PRC2Cleared 510(K)
- K980862TITANIUM SPINAL ROD SYSTEM2Cleared 510(K)
- K980852GII SPINAL FIXATION SYSTEM2Cleared 510(K)
- K981274ACROMED TIMX PLATE BASED LOW BACK SYSTEM2Cleared 510(K)
- K980496WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER2Cleared 510(K)
- K980447DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM2Cleared 510(K)
- K973687SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM2Cleared 510(K)
- K974749SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS2Cleared 510(K)
- K974734AURORA TITANIUM SPINAL ROD SYSTEM2Cleared 510(K)
- K973836SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM2Cleared 510(K)
- K973425THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM2Cleared 510(K)
- K974213AURORA TITANIUM SPINAL ROD SYSTEM2Cleared 510(K)
- K973683OMEGA 21 SYSTEM2Cleared 510(K)
- K972568DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM2Cleared 510(K)
- K971970EBI SPINELINK SYSTEM2Cleared 510(K)
- K970285AESUCLAP SOCON SPINAL SYSTEM2Cleared 510(K)
- K970950EASY ROD2Cleared 510(K)
- K965102ACROMED PEDICLE SCREW2Cleared 510(K)
- K964533EBI SPINELINK SYSTEM2Cleared 510(K)
- K965046ISOLA TWISTER CONNECTOR2Cleared 510(K)
- K963045SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM2Cleared 510(K)
- K964544OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY2Cleared 510(K)
- K964304OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY2Cleared 510(K)
- K950099SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM2Cleared 510(K)
- K963357MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE2Cleared 510(K)
- K964007ACROMED CABLE/WIRE PEDICLE SCREW2Cleared 510(K)
- K962608SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR2Cleared 510(K)
- K962645ISOLA TWISTER CONNECTOR2Cleared 510(K)
- K962784ULTIUM SPINAL PLATING SYSTEM2Cleared 510(K)
- K962757J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP2Cleared 510(K)
- K961572VERSALOK SCREW ASSEMBLY (PROPOSED NAME)2Cleared 510(K)
- K960107DDS SPINAL SYSTEM2Cleared 510(K)
- K960451WEBB-MORLEY SPINE SYSTEM2Cleared 510(K)
- K953881SPINE SYSTEM SACRAL PLATE2Cleared 510(K)
- K953915MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)2Cleared 510(K)
- K950717AUGMENT-T POSTERIOR SPINAL SYSTEM2Cleared 510(K)
- K943827SPINE FIXATION2Cleared 510(K)
- K950999KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS2Cleared 510(K)
- K952236ISOLA SYSTEM2Cleared 510(K)
- K952298SPINAL PEDICLE SCREW, FIXATION, APPLIANCE2Cleared 510(K)
- K951266AMSET R-F SYSTEM2Cleared 510(K)
- K953779SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM2Cleared 510(K)
- K953778SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM2Cleared 510(K)
- K953635TITANIUM DYNA-LOK SPINAL SYSTEM2Cleared 510(K)
- K953416BRYAN POSTERIOR SPINAL FIXATOR (BPSF)2Cleared 510(K)
- K953369STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW2Cleared 510(K)
- K951725OSTEONICS SPINAL SYSTEM2Cleared 510(K)
- K950865ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLT2Cleared 510(K)
- K950596GDLH POSTERIOR SPINAL SYSTEM2Cleared 510(K)
- K950955PARAGON POSTERIOR SPINAL SYSTEM2Cleared 510(K)
- K951657VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S)2Cleared 510(K)
- K951794SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)2Cleared 510(K)
- K951626SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM2Cleared 510(K)
- K936307DYNA-LOK ANTERIOR PLATING SYSTEM2Cleared 510(K)
- K951116ACROMED PEDICLE SCREW2Cleared 510(K)
- K950074WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM2Cleared 510(K)
- K946348TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)2Cleared 510(K)
- K9513085.8MM DIAMETER ANCHOR SCREW2Cleared 510(K)
- K951172TITANIUM LOW PROFILE CROSS BAR2Cleared 510(K)
- K950695DEPUY MOTECH MOSS SPINAL SYSTEM - PEDICLE FIXATION2Cleared 510(K)
- K940631CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM2Cleared 510(K)
- K950697DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION2Cleared 510(K)
- K944737ISOLA SPINE SYSTEM2Cleared 510(K)
- K930353SIMMONS PLATING SYSTEM BOLT AND SCREW2Cleared 510(K)
- K930298ROGOZINSKI SPINAL ROD SYSTEM SCREW2Cleared 510(K)
- K944756ISOLA OPEN AND CLOSED SCREWS2Cleared 510(K)
- K944736VSP (VARIABLE SCREW PLACEMENT)2Cleared 510(K)
- K945064SELBY INSTRUMENTATION2Cleared 510(K)
- K943775SELBY INSTRUMENTATION2Cleared 510(K)
- K942387SELBY INSTRUMENTATION2Cleared 510(K)
- K932029TSRH SPINAL SCREWS2Cleared 510(K)
- MNIOrthosis, Spinal Pedicle Fixation2Product Code
- MNUStaple, Absorbable2Product Code
- MQPSpinal Vertebral Body Replacement Device2Product Code
- MQVFiller, Bone Void, Calcium Compound2Product Code
- MRYAppliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component2Product Code
- NDDCerclage, Fixation, Metallic2Product Code
- NDERod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible2Product Code
- NDFPlate, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDGWasher, Bolt, Nut, Non-Spinal, Metallic2Product Code
- NDJScrew, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDKSystem, External Fixator (With Metallic Invasive Components)2Product Code
- NDLPin, Fixation, Smooth, Metallic2Product Code
- NDMPin, Fixation, Threaded, Metallic2Product Code
- NDNCement, Bone, Vertebroplasty2Product Code
- NJAAccessory, System, External Fixator, Containing Antimicrobial Agent2Product Code
- NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer2Product Code
- NKBThoracolumbosacral Pedicle Screw System2Product Code
- NKGPosterior Cervical Screw System2Product Code
- NOVAnchor, Suture, Bone Fixation, Metallic2Product Code
- NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- NQPPosterior Metal/Polymer Spinal System, Fusion2Product Code
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal2Product Code
- NUDVertebroplasty Compound, Calcium Based2Product Code
- NVCBone, Heterograft3Product Code
- NWNLaparoscopic Bone Anchor Urethropexy Instrument Kit2Product Code
- OBLCement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty2Product Code
- OBMCement, Bone, Vertebroplasty, Pre-Formed, Modular2Product Code
- OBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesis2Product Code
- OCGProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented3Product Code
- ODPIntervertebral Fusion Device With Bone Graft, Cervical2Product Code
- OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation2Product Code
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive2Product Code
- OJBResorbable Spinal Intervertebral Body Fixation Orthosis - Plate2Product Code
- OJMResorbable Spinal Intervertebral Body Fixation Orthosis - Mesh2Product Code
- OOGKnee Arthroplasty Implantation System2Product Code
- OOLElectronic Depth Gauge2Product Code
- OQBIntervertebral Body Graft Containment Device2Product Code
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented2Product Code
- OQHHip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented2Product Code
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented2Product Code
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis2Product Code
- OSNSoftware For Diagnosis/Treatment2Product Code
- OURSacroiliac Joint Fixation2Product Code
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2Product Code
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical2Product Code
- OVZPin, Fixation, Resorbable, Hard Tissue2Product Code
- OWIBone Fixation Cerclage, Sublaminar2Product Code
- OYKAnkle Arthroplasty Implantation System2Product Code
- OZIInternal Hinged Elbow Fixator2Product Code
- PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented2Product Code
- PBFOrthopaedic Surgical Planning And Instrument Guides2Product Code
- PBIProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive2Product Code
- PEKSpinous Process Plate2Product Code
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic2Product Code
- PHQAnterior Staple As Supplemental Fixation For Fusion2Product Code
- PHXShoulder Prosthesis, Reverse Configuration2Product Code
- PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained2Product Code
- PLFBone Wedge2Product Code
- PLRSpinal Vertebral Body Replacement Device - Cervical2Product Code
- PLWAcetabular Cup Orientation System2Product Code
- PMLBone Cement, Posterior Screw Augmentation2Product Code
- PPQTranstibial Anterior Cruciate Ligament Kit2Product Code
- QHQTotal Shoulder Arthroplasty System2Product Code
- PQCPedicle Screw Placement Guide2Product Code
- QACScrew Sleeve Bone Fixation Device2Product Code
- QADRod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated2Product Code
- QFPIntraoperative Orthopedic Strain Sensor2Product Code
- QHEShoulder Arthroplasty Implantation System2Product Code
- QNIResorbable Implant For Anterior Cruciate Ligament (Acl) Repair2Product Code
- QPPImplantable Post-Surgical Kinematic Measurement Knee Device2Product Code
- QPQShoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed2Product Code
- JDJMesh, Surgical, Acetabular, Hip, Prosthesis2Product Code
- JDKProsthesis, Hip, Cement Restrictor2Product Code
- LZNCement Obturator2Product Code
- OLCScaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen2Product Code
- QSDPosterior Cervical Screw Placement Guide2Product Code
- QSRSacroiliac Screw Placement Guide2Product Code
- QVIScrew Sleeve Bone Fixation Device, Spine2Product Code
- QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- QWJMesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- SAIAnkle Fusion Cage2Product Code
- SCYSacroiliac Joint Guidewire Placement Device2Product Code
- 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
OMEGA 21 SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K973683
- 510(k) Type
- Traditional
- Applicant
- EBI ELECTRO BIOLOGY
- Country
- United States
- FDA Decision
- Substantially Equivalent for Some Indications
- Decision Date
- 12/24/1997
- Days to Decision
- 89 days