BEUDAMED
    Product Code: MNI FDA class 2 21 CFR 888.3070

    Orthosis, Spinal Pedicle Fixation

    Orthopedic

    The Orthosis, Spinal Pedicle Fixation is an orthopedic implant used to provide fixation through the pedicles of the vertebrae to stabilize and support the spine. Classified as FDA Class 2 under 21 CFR 888.3070, it requires 510(k) premarket notification demonstrating substantial equivalence. The product code is MNI, reviewed by the Orthopedic panel, and carries an implant flag as it is surgically implanted in the body.

    View on FDA
    510(k)s
    303
    FEI Numbers
    354
    Registration Numbers
    354
    Unique Applicants
    134
    Years Active
    20

    Basic Information

    Product Code
    MNI
    Device Class
    FDA class 2
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 303 510(k) clearances via K numbers.

    K Number Device Name
    K171497 Mikron Spinal Fixation System
    K160731 LumFix Spinal Fixation Sytem
    K151458 Double Medical Universal Spine System
    K153273 MySpine Pedicle Screw Placement Guides - LP
    K160124 LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
    K160320 Premier
    K160003 Sniper (R) Spine System
    K152324 YAHUA Spinal System
    K143222 FIREFLY Pedicle Screw Navigation Guide
    K150684 WASTON General Spinal System
    K152132 X-spine Pedicle Screw System
    K151592 Gemmed pedicle screw spinal system
    K152131 Reliance Spinal Screw System
    K152098 ODALYS Pedicle Screw System
    K152174 Sniper Spine System
    K151813 Sniper Spine System
    K150294 DPZ Pedicular Fixation System
    K150647 Polyscrew Pedicle Screw System
    K150049 PASS LP Spinal System
    K141253 NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
    K140738 PASS LP SPINAL SYSTEM
    K141835 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS
    K141397 SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
    K132788 MYSPINE PEDICLE SCREW PLACEMENT GUIDES
    K140229 GENERAL SPINAL SYSTEM
    K133103 AVERSION PEDICLE SCREW SYSTEM
    K130073 MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS
    K132757 EVEREST SPINAL SYSTEM
    K132280 ALTUS SPINE PEDICLE SCREW SYSTEM
    K130958 TRUE SPINAL FIXATION SYSTEM
    K132412 INERTIA MIS PEDICLE SCREW SYSTEM
    K132361 EVEREST SPINAL SYSTEM
    K132644 LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
    K132365 SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION
    K132154 CAPSURE PS SYSTEM
    K131522 CORE PEDICLE SCREW SYSTEM
    K130302 SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT
    K131343 REFORM PEDICLE SCREW SYSTEM
    K130279 REFORM PEDICLE SCREW SYSTEM
    K123521 RELIANCE SPINAL SCREW SYSTEM
    K122931 S-LOK PSS SYSTEM
    K122163 CERTEX SPINAL IMPLANT SYSTEM
    K122332 TOWERLOX PEDICLE SCREW SYSTEM
    K122233 CAPSURE(R) PS SYSTEM
    K121615 4CIS VANE SPINE SYSTEM
    K121172 REFORM PEDICLE SCREW SYSTEM
    K120646 CAPSURE(R) PS SYSTEM
    K120899 RANGE SPINAL SYSTEM, UNIT ROD
    K120879 LEXUS CERVICAL FIXATION SYSTEM
    K120099 RANGE SPINAL SYSTEM (MESA AND DENALI)
    K112611 SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS
    K120292 CAPLOX II PEDICLE SCREW SYSTEM
    K120656 EVEREST SPINAL SYSTEM
    K120696 TIGER SPINE SYSTEM
    K120538 PALLS M SPINAL SYSTEM
    K113157 AILERON INTERSPINOUS FIXATION SYSTEM
    K113755 SAVANNAH TECHNOLOGIES SPINAL SYSTEM
    K113149 SYNTHES USS CONNECTORS
    K110896 RELIANCE SPINAL SCREW SYSTEM
    K112920 RANGE SPINAL SYSTEM (MESA AND DENALI)
    K112484 ZAVATION SPINAL SYSTEM
    K112493 PASS LP SPINAL SYSTEM
    K111883 SMARTLOC SPINAL FIXATION SYSTEM
    K112037 RANGE SPINAL SYSTEM (MESA AND DENALI)
    K111115 CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM
    K111913 CAPSURE(R) PS SYSTEM
    K112108 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
    K111127 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
    K110991 MESA SPINAL SYSTEM (KEYSTONE RODS)
    K103414 VENUS CERVICAL SPINAL FIXATION SYSTEM
    K110197 EXACTECH GIBRALT SPINAL SYSTEM
    K110284 NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
    K110283 ZENIUS SPINAL SYSTEM
    K103440 EVEREST SPINAL SYSTEM
    K103102 LEUCADIA PEDICLE SCREW SYSTEM
    K102995 TALON SPINAL SYSTEM
    K103272 ZENIUS SPINAL SYSTEM
    K103147 NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
    K101682 S 100 PEDICLE SCREW SYSTEM
    K103100 MOUNTAINEER OCT SPINAL SYSTEM
    K100407 LIFE SPINE INTERSPINOUS FIXATION SYSTEM
    K102331 LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
    K093833 KAPSS SPINAL SYSTEM
    K100851 RANGE SPINAL SYSTEM
    K100765 FIXPINE II SYSTEM
    K093104 MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM
    K100377 DIAMONDBACK SPINAL SYSTEM
    K092076 AEGIS & AEGIS II SPINAL SYSTEM
    K100575 LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
    K093936 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
    K100297 PASS LP SPINAL SYSTEM
    K100138 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
    K093077 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
    K093285 MODIFICATION TO LANX SPINAL FIXATION SYSTEM
    K092420 KRD1 PEDICLE SCREW SYSTEM
    K092640 CASPIAN SPINAL SYSTEM
    K093170 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
    K092128 MODIFICATION TO: PSS SYSTEM
    K083810 PASS LP SPINAL SYSTEM
    K091189 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
    K090779 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
    K090984 INERTIA PEDICLE SCREW SYSTEM
    K090033 MODIFICATION TO: PSS SYSTEM
    K083863 THEKEN ATOLL OCT SPINAL SYSTEM
    K081978 RELIANCE SPINAL SCREW SYSTEM
    K083073 THEKEN ATOLL CERVICO-THORACIC SYSTEM
    K083178 SOLAS ANATOMIX SPINAL SYSTEM
    K083865 PILOT SPINAL SYSTEM
    K082617 TRAUSON GENERAL SPINAL SYSTEM (GSS)
    K083743 CAPSURE PS SYSTEM
    K083353 CAPSURE(R) PS SYSTEM
    K083308 PASS LP SPINAL SYSTEM
    K081145 MODIFICATION TO 4CIS VANE SPINE SYSTEM
    K082069 PASS 2 SPINAL SYSTEM
    K081790 MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM
    K080841 COSMIC SYSTEM
    K081158 ZODIC POLYAXIAL SPINAL FIXATION SYSTEM
    K081597 MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM
    K071668 ORTHOBIOM SPINAL SYSTEM
    K071074 MYKRES SPINAL SYSTEM
    K080767 CONQUEST SPINAL SYSTEM
    K081228 CAPSURE PS (R) SPINE SYSTEM
    K080099 PASS SPINAL SYSTEM
    K080792 K2M COCR ROD
    K080502 MODIFICATION TO:PILOT SPINAL SYSTEM
    K073143 MODIFIED VERTIFLEX SPINAL SCREW SYSTEM
    K073240 PSS SYSTEM
    K080407 BLACKSTONE SFS PARALLEL ROD CONNECTORS
    K080143 MODIFICATION TO STRYKER SPINE OASYS SYSTEM
    K080075 MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM
    K080026 QUANTUM-MIS CANNULATED SYSTEM
    K072434 SYNTHES OC FUSION AND SYNAPSE SYSTEMS
    K072914 NATURAL BRIDGE LP TRANSVERSE CONNECTORS
    K072436 MEGA SPINE SYSTEM
    K072187 PIONEER LOWTOP SPINAL ROD SYSTEM
    K071880 Optima ZS Transition Screw
    K070276 MODIFICATION TO PASSMED SPINAL SYSTEM
    K071877 LANX SPINAL FIXATION SYSTEM
    K071824 ACME TALON PEDICLE SCREW
    K063453 VERTEFIX PEDICLE SCREW SPINAL SYSTEM
    K071438 PSS SYSTEM
    K071857 DELTA SPINAL FUSION SYSTEM
    K071435 NUVASIVE OCT SYSTEM
    K071743 PILLAR PEDICLE SCREW SYSTEM
    K070573 SYNAPSE SYSTEM
    K070295 SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM
    K063668 ROC LUMBAR SYSTEM
    K070229 RANGE SPINAL SYSTEM
    K063708 4S SPINAL SYSTEM
    K070245 CAPSURE PEDICLE SCREW SYSTEM
    K062912 SCIENT'X SPINAL SYSTEM
    K063601 PILOT SPINAL SYSTEM
    K063794 MODIFICATION TO EASYSPINE SYSTEM
    K062879 TRAVERSE OCT SPINAL FIXATION SYSTEM
    K062934 SIERRA
    K062853 MODIFICATION TO STRYKER SPINE OASYS SYSTEM
    K062698 TRIO + SPINAL SYSTEM
    K062136 PASS 2 SPINAL SYSTEM
    K062505 NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES
    K062606 CD HORIZON SPINAL SYSTEM
    K061600 ARX SPINAL SYSTEM
    K061978 EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM
    K061017 EASYSPINE SYSTEM
    K051704 MYKRES SPINAL SYSTEM
    K060634 NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES
    K060152 MODIFICATION TO S4 SPINAL SYSTEM
    K052566 NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY
    K053483 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
    K052847 CAPLESS PEDICLE SCREW SYSTEM
    K052398 MESA SPINAL SYSTEM
    K053115 XIA SPINAL SYSTEM
    K052971 STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
    K052406 UNI-THREAD SPINAL SYSTEM
    K052761 MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
    K052317 MODIFICATION TO: STRYKER SPINE OASYS SYSTEM
    K050979 S4 SPINAL SYSTEM
    K051063 POLYAXIAL HEMISPHERICAL SPINAL SCREWS
    K050981 CD HORIZON SPINAL SYSTEM
    K043484 LANX SPINAL FIXATION SYSTEM
    K050060 LAGUNA PEDICLE SCREW SYSTEM
    K050675 EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE
    K043094 EASYSPINE SYSTEM
    K042210 MSD SILO SPINAL SYSTEM
    K042514 MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
    K042453 MODIFICATION TO EQUATION FIXATION SYSTEM
    K042100 BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
    K041777 MODIFICATION TO CD HORIZON SPINAL SYSTEM
    K040493 OUTOLOGOUS SPINAL FIXATION SYSTEM
    K033826 ORTHOPEDIC ALLIANCE SPINE SYSTEM
    K041030 MODIFICATION TO CD HORIZON SPINAL SYSTEM
    K041203 SUMMIT OCT SPINAL SYSTEM
    K041118 MODIFICATION TO CD HORIZON SPINAL SYSTEM
    K040583 MODIFICATION TO: CD HORIZON SPINAL SYSTEM
    K040346 MODIFICATION TO ORIA TOP CLIP SYSTEM
    K033947 SHIRAZ POSTERIOR SYSTEM
    K033150 ART POSTERIOR SPINAL SYSTEM
    K033352 VERTEBRON PSS PEDICLE SCREW SYSTEM
    K032394 STRYKER SPINE OASYS SYSTEM
    K040034 BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER
    K033772 SHIRAZ-JAVA SPINAL FIXATION SYSTEM
    K033508 PLUS PIVOT LINK UNIVERSAL SYSTEM
    K022908 POSTERIOR CABLE SCREW
    K032219 REVOLUTION SPINAL FIXATION SYSTEM
    K033495 MODIFICATION TO EQUATION FIXATION SYSTEM
    K032739 UCR SPINAL SYSTEM
    K030958 ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
    K033271 DYNALOK CLASSIC SPINAL SYSTEM
    K032398 PLUS PIVOT LINK UNIVERSAL SYSTEM
    K031455 CONKLUSION PEDICLE SCREW SYSTEM
    K032578 TSRH SPINAL SYSTEM
    K031967 TSRH SPINAL SYSTEM
    K031985 SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM
    K032037 CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
    K031833 MODIFICATION TO CD HORIZON SPINAL SYSTEM
    K024313 MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
    K031354 EBI OMEGA21 SPINAL FIXATION SYSTEM
    K031381 UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS
    K031888 MODIFICATION TO CD HORIZON SPINAL SYSTEM
    K031655 CD HORIZON SPINAL SYSTEM
    K030932 CD HORIZON SPINAL SYSTEM
    K030840 MODIFICATION TO HORIZON SPINAL SYSTEM
    K030862 BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR
    K022949 SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
    K024096 OPTIMA, SPINAL SYSTEM
    K030377 MODIFICATION TO SYNTHES CERVIFIX SYSTEM
    K030103 SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS
    K023299 ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
    K023644 MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM
    K022768 AMT POLYAXIAL PEDICLE SCREW
    K022271 PLUS PIVOT LINK UNIVERSAL SYSTEM
    K022778 MODIFICATION TO TSRH SPINAL SYSTEM
    K022285 MODIFICATION TO ISOLA SPINAL SYSTEM
    K022160 XIA SPINAL SYSTEM
    K021510 UNI-T UNI-THREAD SPINAL SYSTEM
    K022190 MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
    K021275 MICOMED POSTERIOR DOUBLEROD SYSTEM
    K020279 FOREX CORPORATION, OPTIMA, SPINAL SYSTEM
    K021379 SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
    K021106 MODIFICATION TO TSRH SPINAL SYSTEM
    K020517 SYNTHES DUAL-OPENING USS
    K013301 UNI-T SPINAL SYSTEM
    K013885 BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS
    K013440 ISOBAR SPINAL SYSTEM
    K013431 PASS SPINAL SYSTEM
    K013403 TRI-FIX SPINAL FIXATION SYSTEM
    K013222 SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM
    K013191 PASS SPINAL SYSTEM
    K011807 SCS CLARIS SPINAL SCREWS, TYPES V,G,E
    K012175 PASS SPINAL SYSTEM
    K010972 ISOLA BAND CLAMP
    K011437 SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
    K010922 TRI-FIX SPINAL FIXATION SYSTEM
    K010903 TRI-FIX SPINAL FIXATION SYSTEM
    K010108 USS-LINE EXTENSION
    K011029 MODIFICATION TO TSRH SPINAL SYSTEM
    K010658 MODIFIED USS FRACTURE SYSTEM
    K010563 END-TO-END AND SIDE-BY-SIDE CONNECTORS
    K010576 MONARCH SPINE SYSTEM
    K003735 BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
    K011067 MODIFICATION TO TSRH SPINAL SYSTEM
    K994121 SMALL STATURE USS
    K000766 TRI-FIX SPINAL FIXATION SYSTEM
    K000965 MULTI-AXIAL CROSS (MAC) CONNECTOR
    K000991 MODIFICATION TO TSRH SPINAL SYSTEM
    K000876 SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP
    K001037 MODIFICATION TO EBI SPINELINK SYSTEM
    K000450 MODIFICATION TO SYNTHES USS
    K000425 ISOBAR SPINAL SYSTEM
    K992147 TRIPLE-FIX SPINAL FIXATION SYSTEM
    K000236 SYNERGY VLS CAP NUT MODELS 2206, 6102
    K991862 MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS)
    K993402 OPUS SPINAL SYSTEM
    K992920 EBI SPINELINK SYSTEM
    K992738 ISOBAR SPINAL SYSTEM
    K991326 ISOBAR SEMI-RIGID SPINAL SYSTEM
    K992369 SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22
    K992333 EBI OMEGA 21 SYSTEM
    K992276 MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
    K992928 CD HORIZON SPINAL SYSTEM
    K991721 EBI OMEGA 21 SYSTEM
    K990057 SYNERGY ADJUSTABLE LENGTH ROD
    K990745 MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
    K984578 SYNERGY D2 SPINAL IMPLANTS
    K990158 OSTEONICS COMBINATION SCREW RING/BLOCKER
    K990059 OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS
    K984350 VSP SYSTEM
    K984348 TIMX LOW BACK SYSTEM
    K984612 SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM
    K984027 EBI SPINELINK SYSTEM
    K984522 MODIFICATION OF TSRH SPINAL SYSTEM
    K984378 DEPUY ACROMED MOSS SPINAL SYSTEM
    K980184 CD SPINAL SYSTEM
    K983672 DYNA-LOK SPINAL SYSTEM
    K983260 MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM
    K983258 MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM
    K982990 TSRH SPINAL SYSTEM
    K982987 SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
    K980485 ISOLA SPINAL SYSTEM
    K982914 AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS
    K980484 AESCULAP SPINE SYSTEM EVOLUTION
    K982686 MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM
    K982154 MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
    K970599 TOWNLEY PEDICLE SCREW PLATING SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 354 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 354 registration numbers. Click on an entry to view related FDA registrations.