Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
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- Obstetrical and GynecologicalReview Panel
- OphthalmicReview 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
- MNIOrthosis, Spinal Pedicle Fixation2Product Code
- K171497Mikron Spinal Fixation System2Cleared 510(K)
- K160731LumFix Spinal Fixation Sytem2Cleared 510(K)
- K151458Double Medical Universal Spine System2Cleared 510(K)
- K153273MySpine Pedicle Screw Placement Guides - LP2Cleared 510(K)
- K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System2Cleared 510(K)
- K160320Premier2Cleared 510(K)
- K160003Sniper (R) Spine System2Cleared 510(K)
- K152324YAHUA Spinal System2Cleared 510(K)
- K143222FIREFLY Pedicle Screw Navigation Guide2Cleared 510(K)
- K150684WASTON General Spinal System2Cleared 510(K)
- K152132X-spine Pedicle Screw System2Cleared 510(K)
- K151592Gemmed pedicle screw spinal system2Cleared 510(K)
- K152131Reliance Spinal Screw System2Cleared 510(K)
- K152098ODALYS Pedicle Screw System2Cleared 510(K)
- K152174Sniper Spine System2Cleared 510(K)
- K151813Sniper Spine System2Cleared 510(K)
- K150294DPZ Pedicular Fixation System2Cleared 510(K)
- K150647Polyscrew Pedicle Screw System2Cleared 510(K)
- K150049PASS LP Spinal System2Cleared 510(K)
- K141253NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM2Cleared 510(K)
- K140738PASS LP SPINAL SYSTEM2Cleared 510(K)
- K141835ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS2Cleared 510(K)
- K141397SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM2Cleared 510(K)
- K132788MYSPINE PEDICLE SCREW PLACEMENT GUIDES2Cleared 510(K)
- K140229GENERAL SPINAL SYSTEM2Cleared 510(K)
- K133103AVERSION PEDICLE SCREW SYSTEM2Cleared 510(K)
- K130073MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS2Cleared 510(K)
- K132757EVEREST SPINAL SYSTEM2Cleared 510(K)
- K132280ALTUS SPINE PEDICLE SCREW SYSTEM2Cleared 510(K)
- K130958TRUE SPINAL FIXATION SYSTEM2Cleared 510(K)
- K132412INERTIA MIS PEDICLE SCREW SYSTEM2Cleared 510(K)
- K132361EVEREST SPINAL SYSTEM2Cleared 510(K)
- K132644LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU2Cleared 510(K)
- K132365SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION2Cleared 510(K)
- K132154CAPSURE PS SYSTEM2Cleared 510(K)
- K131522CORE PEDICLE SCREW SYSTEM2Cleared 510(K)
- K130302SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT2Cleared 510(K)
- K131343REFORM PEDICLE SCREW SYSTEM2Cleared 510(K)
- K130279REFORM PEDICLE SCREW SYSTEM2Cleared 510(K)
- K123521RELIANCE SPINAL SCREW SYSTEM2Cleared 510(K)
- K122931S-LOK PSS SYSTEM2Cleared 510(K)
- K122163CERTEX SPINAL IMPLANT SYSTEM2Cleared 510(K)
- K122332TOWERLOX PEDICLE SCREW SYSTEM2Cleared 510(K)
- K122233CAPSURE(R) PS SYSTEM2Cleared 510(K)
- K1216154CIS VANE SPINE SYSTEM2Cleared 510(K)
- K121172REFORM PEDICLE SCREW SYSTEM2Cleared 510(K)
- K120646CAPSURE(R) PS SYSTEM2Cleared 510(K)
- K120899RANGE SPINAL SYSTEM, UNIT ROD2Cleared 510(K)
- K120879LEXUS CERVICAL FIXATION SYSTEM2Cleared 510(K)
- K120099RANGE SPINAL SYSTEM (MESA AND DENALI)2Cleared 510(K)
- K112611SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS2Cleared 510(K)
- K120292CAPLOX II PEDICLE SCREW SYSTEM2Cleared 510(K)
- K120656EVEREST SPINAL SYSTEM2Cleared 510(K)
- K120696TIGER SPINE SYSTEM2Cleared 510(K)
- K120538PALLS M SPINAL SYSTEM2Cleared 510(K)
- K113157AILERON INTERSPINOUS FIXATION SYSTEM2Cleared 510(K)
- K113755SAVANNAH TECHNOLOGIES SPINAL SYSTEM2Cleared 510(K)
- K113149SYNTHES USS CONNECTORS2Cleared 510(K)
- K110896RELIANCE SPINAL SCREW SYSTEM2Cleared 510(K)
- K112920RANGE SPINAL SYSTEM (MESA AND DENALI)2Cleared 510(K)
- K112484ZAVATION SPINAL SYSTEM2Cleared 510(K)
- K112493PASS LP SPINAL SYSTEM2Cleared 510(K)
- K111883SMARTLOC SPINAL FIXATION SYSTEM2Cleared 510(K)
- K112037RANGE SPINAL SYSTEM (MESA AND DENALI)2Cleared 510(K)
- K111115CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM2Cleared 510(K)
- K111913CAPSURE(R) PS SYSTEM2Cleared 510(K)
- K112108ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K111127ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K110991MESA SPINAL SYSTEM (KEYSTONE RODS)2Cleared 510(K)
- K103414VENUS CERVICAL SPINAL FIXATION SYSTEM2Cleared 510(K)
- K110197EXACTECH GIBRALT SPINAL SYSTEM2Cleared 510(K)
- K110284NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM2Cleared 510(K)
- K110283ZENIUS SPINAL SYSTEM2Cleared 510(K)
- K103440EVEREST SPINAL SYSTEM2Cleared 510(K)
- K103102LEUCADIA PEDICLE SCREW SYSTEM2Cleared 510(K)
- K102995TALON SPINAL SYSTEM2Cleared 510(K)
- K103272ZENIUS SPINAL SYSTEM2Cleared 510(K)
- K103147NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM2Cleared 510(K)
- K101682S 100 PEDICLE SCREW SYSTEM2Cleared 510(K)
- K103100MOUNTAINEER OCT SPINAL SYSTEM2Cleared 510(K)
- K100407LIFE SPINE INTERSPINOUS FIXATION SYSTEM2Cleared 510(K)
- K102331LDR SPINE USA SPINETUNE TL SPINAL SYSTEM2Cleared 510(K)
- K093833KAPSS SPINAL SYSTEM2Cleared 510(K)
- K100851RANGE SPINAL SYSTEM2Cleared 510(K)
- K100765FIXPINE II SYSTEM2Cleared 510(K)
- K093104MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM2Cleared 510(K)
- K100377DIAMONDBACK SPINAL SYSTEM2Cleared 510(K)
- K092076AEGIS & AEGIS II SPINAL SYSTEM2Cleared 510(K)
- K100575LDR SPINE USA SPINE TUNE TL SPINE SYSTEM2Cleared 510(K)
- K093936ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K100297PASS LP SPINAL SYSTEM2Cleared 510(K)
- K100138ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM2Cleared 510(K)
- K093077ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM2Cleared 510(K)
- K093285MODIFICATION TO LANX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K092420KRD1 PEDICLE SCREW SYSTEM2Cleared 510(K)
- K092640CASPIAN SPINAL SYSTEM2Cleared 510(K)
- K093170ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K092128MODIFICATION TO: PSS SYSTEM2Cleared 510(K)
- K083810PASS LP SPINAL SYSTEM2Cleared 510(K)
- K091189ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM2Cleared 510(K)
- K090779ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM2Cleared 510(K)
- K090984INERTIA PEDICLE SCREW SYSTEM2Cleared 510(K)
- K090033MODIFICATION TO: PSS SYSTEM2Cleared 510(K)
- K083863THEKEN ATOLL OCT SPINAL SYSTEM2Cleared 510(K)
- K081978RELIANCE SPINAL SCREW SYSTEM2Cleared 510(K)
- K083073THEKEN ATOLL CERVICO-THORACIC SYSTEM2Cleared 510(K)
- K083178SOLAS ANATOMIX SPINAL SYSTEM2Cleared 510(K)
- K083865PILOT SPINAL SYSTEM2Cleared 510(K)
- K082617TRAUSON GENERAL SPINAL SYSTEM (GSS)2Cleared 510(K)
- K083743CAPSURE PS SYSTEM2Cleared 510(K)
- K083353CAPSURE(R) PS SYSTEM2Cleared 510(K)
- K083308PASS LP SPINAL SYSTEM2Cleared 510(K)
- K081145MODIFICATION TO 4CIS VANE SPINE SYSTEM2Cleared 510(K)
- K082069PASS 2 SPINAL SYSTEM2Cleared 510(K)
- K081790MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM2Cleared 510(K)
- K080841COSMIC SYSTEM2Cleared 510(K)
- K081158ZODIC POLYAXIAL SPINAL FIXATION SYSTEM2Cleared 510(K)
- K081597MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM2Cleared 510(K)
- K071668ORTHOBIOM SPINAL SYSTEM2Cleared 510(K)
- K071074MYKRES SPINAL SYSTEM2Cleared 510(K)
- K080767CONQUEST SPINAL SYSTEM2Cleared 510(K)
- K081228CAPSURE PS (R) SPINE SYSTEM2Cleared 510(K)
- K080099PASS SPINAL SYSTEM2Cleared 510(K)
- K080792K2M COCR ROD2Cleared 510(K)
- K080502MODIFICATION TO:PILOT SPINAL SYSTEM2Cleared 510(K)
- K073143MODIFIED VERTIFLEX SPINAL SCREW SYSTEM2Cleared 510(K)
- K073240PSS SYSTEM2Cleared 510(K)
- K080407BLACKSTONE SFS PARALLEL ROD CONNECTORS2Cleared 510(K)
- K080143MODIFICATION TO STRYKER SPINE OASYS SYSTEM2Cleared 510(K)
- K080075MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM2Cleared 510(K)
- K080026QUANTUM-MIS CANNULATED SYSTEM2Cleared 510(K)
- K072434SYNTHES OC FUSION AND SYNAPSE SYSTEMS2Cleared 510(K)
- K072914NATURAL BRIDGE LP TRANSVERSE CONNECTORS2Cleared 510(K)
- K072436MEGA SPINE SYSTEM2Cleared 510(K)
- K072187PIONEER LOWTOP SPINAL ROD SYSTEM2Cleared 510(K)
- K071880Optima ZS Transition Screw2Cleared 510(K)
- K070276MODIFICATION TO PASSMED SPINAL SYSTEM2Cleared 510(K)
- K071877LANX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K071824ACME TALON PEDICLE SCREW2Cleared 510(K)
- K063453VERTEFIX PEDICLE SCREW SPINAL SYSTEM2Cleared 510(K)
- K071438PSS SYSTEM2Cleared 510(K)
- K071857DELTA SPINAL FUSION SYSTEM2Cleared 510(K)
- K071435NUVASIVE OCT SYSTEM2Cleared 510(K)
- K071743PILLAR PEDICLE SCREW SYSTEM2Cleared 510(K)
- K070573SYNAPSE SYSTEM2Cleared 510(K)
- K070295SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM2Cleared 510(K)
- K063668ROC LUMBAR SYSTEM2Cleared 510(K)
- K070229RANGE SPINAL SYSTEM2Cleared 510(K)
- K0637084S SPINAL SYSTEM2Cleared 510(K)
- K070245CAPSURE PEDICLE SCREW SYSTEM2Cleared 510(K)
- K062912SCIENT'X SPINAL SYSTEM2Cleared 510(K)
- K063601PILOT SPINAL SYSTEM2Cleared 510(K)
- K063794MODIFICATION TO EASYSPINE SYSTEM2Cleared 510(K)
- K062879TRAVERSE OCT SPINAL FIXATION SYSTEM2Cleared 510(K)
- K062934SIERRA2Cleared 510(K)
- K062853MODIFICATION TO STRYKER SPINE OASYS SYSTEM2Cleared 510(K)
- K062698TRIO + SPINAL SYSTEM2Cleared 510(K)
- K062136PASS 2 SPINAL SYSTEM2Cleared 510(K)
- K062505NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES2Cleared 510(K)
- K062606CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K061600ARX SPINAL SYSTEM2Cleared 510(K)
- K061978EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM2Cleared 510(K)
- K061017EASYSPINE SYSTEM2Cleared 510(K)
- K051704MYKRES SPINAL SYSTEM2Cleared 510(K)
- K060634NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES2Cleared 510(K)
- K060152MODIFICATION TO S4 SPINAL SYSTEM2Cleared 510(K)
- K052566NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY2Cleared 510(K)
- K053483MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM2Cleared 510(K)
- K052847CAPLESS PEDICLE SCREW SYSTEM2Cleared 510(K)
- K052398MESA SPINAL SYSTEM2Cleared 510(K)
- K053115XIA SPINAL SYSTEM2Cleared 510(K)
- K052971STRYKER SPINE TRIO SPINAL FIXATION SYSTEM2Cleared 510(K)
- K052406UNI-THREAD SPINAL SYSTEM2Cleared 510(K)
- K052761MODIFICATION TO: XIA 4.5 SPINAL SYSTEM2Cleared 510(K)
- K052317MODIFICATION TO: STRYKER SPINE OASYS SYSTEM2Cleared 510(K)
- K050979S4 SPINAL SYSTEM2Cleared 510(K)
- K051063POLYAXIAL HEMISPHERICAL SPINAL SCREWS2Cleared 510(K)
- K050981CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K043484LANX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K050060LAGUNA PEDICLE SCREW SYSTEM2Cleared 510(K)
- K050675EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE2Cleared 510(K)
- K043094EASYSPINE SYSTEM2Cleared 510(K)
- K042210MSD SILO SPINAL SYSTEM2Cleared 510(K)
- K042514MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM2Cleared 510(K)
- K042453MODIFICATION TO EQUATION FIXATION SYSTEM2Cleared 510(K)
- K042100BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR2Cleared 510(K)
- K041777MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K040493OUTOLOGOUS SPINAL FIXATION SYSTEM2Cleared 510(K)
- K033826ORTHOPEDIC ALLIANCE SPINE SYSTEM2Cleared 510(K)
- K041030MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K041203SUMMIT OCT SPINAL SYSTEM2Cleared 510(K)
- K041118MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K040583MODIFICATION TO: CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K040346MODIFICATION TO ORIA TOP CLIP SYSTEM2Cleared 510(K)
- K033947SHIRAZ POSTERIOR SYSTEM2Cleared 510(K)
- K033150ART POSTERIOR SPINAL SYSTEM2Cleared 510(K)
- K033352VERTEBRON PSS PEDICLE SCREW SYSTEM2Cleared 510(K)
- K032394STRYKER SPINE OASYS SYSTEM2Cleared 510(K)
- K040034BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER2Cleared 510(K)
- K033772SHIRAZ-JAVA SPINAL FIXATION SYSTEM2Cleared 510(K)
- K033508PLUS PIVOT LINK UNIVERSAL SYSTEM2Cleared 510(K)
- K022908POSTERIOR CABLE SCREW2Cleared 510(K)
- K032219REVOLUTION SPINAL FIXATION SYSTEM2Cleared 510(K)
- K033495MODIFICATION TO EQUATION FIXATION SYSTEM2Cleared 510(K)
- K032739UCR SPINAL SYSTEM2Cleared 510(K)
- K030958ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS2Cleared 510(K)
- K033271DYNALOK CLASSIC SPINAL SYSTEM2Cleared 510(K)
- K032398PLUS PIVOT LINK UNIVERSAL SYSTEM2Cleared 510(K)
- K031455CONKLUSION PEDICLE SCREW SYSTEM2Cleared 510(K)
- K032578TSRH SPINAL SYSTEM2Cleared 510(K)
- K031967TSRH SPINAL SYSTEM2Cleared 510(K)
- K031985SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM2Cleared 510(K)
- K032037CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)2Cleared 510(K)
- K031833MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K024313MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM2Cleared 510(K)
- K031354EBI OMEGA21 SPINAL FIXATION SYSTEM2Cleared 510(K)
- K031381UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS2Cleared 510(K)
- K031888MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K031655CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K030932CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K030840MODIFICATION TO HORIZON SPINAL SYSTEM2Cleared 510(K)
- K030862BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR2Cleared 510(K)
- K022949SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS2Cleared 510(K)
- K024096OPTIMA, SPINAL SYSTEM2Cleared 510(K)
- K030377MODIFICATION TO SYNTHES CERVIFIX SYSTEM2Cleared 510(K)
- K030103SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS2Cleared 510(K)
- K023299ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM2Cleared 510(K)
- K023644MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM2Cleared 510(K)
- K022768AMT POLYAXIAL PEDICLE SCREW2Cleared 510(K)
- K022271PLUS PIVOT LINK UNIVERSAL SYSTEM2Cleared 510(K)
- K022778MODIFICATION TO TSRH SPINAL SYSTEM2Cleared 510(K)
- K022285MODIFICATION TO ISOLA SPINAL SYSTEM2Cleared 510(K)
- K022160XIA SPINAL SYSTEM2Cleared 510(K)
- K021510UNI-T UNI-THREAD SPINAL SYSTEM2Cleared 510(K)
- K022190MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM2Cleared 510(K)
- K021275MICOMED POSTERIOR DOUBLEROD SYSTEM2Cleared 510(K)
- K020279FOREX CORPORATION, OPTIMA, SPINAL SYSTEM2Cleared 510(K)
- K021379SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL062Cleared 510(K)
- K021106MODIFICATION TO TSRH SPINAL SYSTEM2Cleared 510(K)
- K020517SYNTHES DUAL-OPENING USS2Cleared 510(K)
- K013301UNI-T SPINAL SYSTEM2Cleared 510(K)
- K013885BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS2Cleared 510(K)
- K013440ISOBAR SPINAL SYSTEM2Cleared 510(K)
- K013431PASS SPINAL SYSTEM2Cleared 510(K)
- K013403TRI-FIX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K013222SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM2Cleared 510(K)
- K013191PASS SPINAL SYSTEM2Cleared 510(K)
- K011807SCS CLARIS SPINAL SCREWS, TYPES V,G,E2Cleared 510(K)
- K012175PASS SPINAL SYSTEM2Cleared 510(K)
- K010972ISOLA BAND CLAMP2Cleared 510(K)
- K011437SYNERGY 4.0 MM, 4.5 MM VLS SCREWS2Cleared 510(K)
- K010922TRI-FIX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K010903TRI-FIX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K010108USS-LINE EXTENSION2Cleared 510(K)
- K011029MODIFICATION TO TSRH SPINAL SYSTEM2Cleared 510(K)
- K010658MODIFIED USS FRACTURE SYSTEM2Cleared 510(K)
- K010563END-TO-END AND SIDE-BY-SIDE CONNECTORS2Cleared 510(K)
- K010576MONARCH SPINE SYSTEM2Cleared 510(K)
- K003735BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR2Cleared 510(K)
- K011067MODIFICATION TO TSRH SPINAL SYSTEM2Cleared 510(K)
- K994121SMALL STATURE USS2Cleared 510(K)
- K000766TRI-FIX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K000965MULTI-AXIAL CROSS (MAC) CONNECTOR2Cleared 510(K)
- K000991MODIFICATION TO TSRH SPINAL SYSTEM2Cleared 510(K)
- K000876SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP2Cleared 510(K)
- K001037MODIFICATION TO EBI SPINELINK SYSTEM2Cleared 510(K)
- K000450MODIFICATION TO SYNTHES USS2Cleared 510(K)
- K000425ISOBAR SPINAL SYSTEM2Cleared 510(K)
- K992147TRIPLE-FIX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K000236SYNERGY VLS CAP NUT MODELS 2206, 61022Cleared 510(K)
- K991862MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS)2Cleared 510(K)
- K993402OPUS SPINAL SYSTEM2Cleared 510(K)
- K992920EBI SPINELINK SYSTEM2Cleared 510(K)
- K992738ISOBAR SPINAL SYSTEM2Cleared 510(K)
- K991326ISOBAR SEMI-RIGID SPINAL SYSTEM2Cleared 510(K)
- K992369SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,222Cleared 510(K)
- K992333EBI OMEGA 21 SYSTEM2Cleared 510(K)
- K992276MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM2Cleared 510(K)
- K992928CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K991721EBI OMEGA 21 SYSTEM2Cleared 510(K)
- K990057SYNERGY ADJUSTABLE LENGTH ROD2Cleared 510(K)
- K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM2Cleared 510(K)
- K984578SYNERGY D2 SPINAL IMPLANTS2Cleared 510(K)
- K990158OSTEONICS COMBINATION SCREW RING/BLOCKER2Cleared 510(K)
- K990059OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS2Cleared 510(K)
- K984350VSP SYSTEM2Cleared 510(K)
- K984348TIMX LOW BACK SYSTEM2Cleared 510(K)
- K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM2Cleared 510(K)
- K984027EBI SPINELINK SYSTEM2Cleared 510(K)
- K984522MODIFICATION OF TSRH SPINAL SYSTEM2Cleared 510(K)
- K984378DEPUY ACROMED MOSS SPINAL SYSTEM2Cleared 510(K)
- K980184CD SPINAL SYSTEM2Cleared 510(K)
- K983672DYNA-LOK SPINAL SYSTEM2Cleared 510(K)
- K983260MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM2Cleared 510(K)
- K983258MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K982990TSRH SPINAL SYSTEM2Cleared 510(K)
- K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM2Cleared 510(K)
- K980485ISOLA SPINAL SYSTEM2Cleared 510(K)
- K982914AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS2Cleared 510(K)
- K980484AESCULAP SPINE SYSTEM EVOLUTION2Cleared 510(K)
- K982686MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM2Cleared 510(K)
- K982154MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM2Cleared 510(K)
- K970599TOWNLEY PEDICLE SCREW PLATING SYSTEM2Cleared 510(K)
- 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
Polyscrew Pedicle Screw System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K150647
- 510(k) Type
- Special
- Applicant
- New Era Orthopedics, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/8/2015
- Days to Decision
- 27 days
- Submission Type
- Summary