BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Micro Pituitary(Straight) (END-MPS2M)

    Reg #: 3015426608 · FEI: 3015426608 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    109
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Medynus, Inc.
    Registration Number
    3015426608
    FEI Number
    3015426608
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    18 Technology Dr. Suite 109
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212792

    Owner / Operator

    Firm Name
    Medynus, Inc.
    Operator Number
    10060045
    Address
    18 Technology Dr. Suite 109
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Daewon Shin

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    Micro Pituitary(Straight) (END-MPS2M) CCN-00002 (AC.2090) ACDF Trial (Lordotic) L12 x W14 x A7 x H6 CCN-00051 (AC400) Cervical Cage holder Serial Dilator 1 (END-SD001) Rotator Kerrison Curved Head(2mm) (END-RKCH2) Curved Kerrison 2mm (END-CK02M) Hockey Chisel(Right 5mm) (END-OTR5M) Dilator (END-MD001) Chisel(Stright 5mm) (END-OTS5M) Bone Curette(Reverse 3mm) (END-CUR3M) UV Retractor(40mm) (END-WT040) Verana (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage and Instrument sets including its containers Micro Pituitary(Up) (END-MPU2M) Rotator Kerrison Handle (END-RKH01) CCN-00003 (AC.2091) ACDF Trial (Lordotic) L12 x W14 x A7 x H7 Root Retractor (END-RR001) UV Retractor(50mm) (END-WT050) CCN-00004 (AC.2092) ACDF Trial (Lordotic) L12 x W14 x A7 x H8 CCN-00014 (AC.2110) ACDF Trial (Lordotic) L14 x W14 x A7 x H10 Pixie (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage Trial Anatomic dual 12*14*7-8mm Trial Lordotic 14*16*7mm (CCN-00011) Trial Lordotic dual 14*16*11-12mm Trial Anatomic dual 14*16*5-6mm Trial Lordotic dual 12*14*9-10mm Cervical Cage Anatomic Implant Caddy (CNR-00003) Trial Lordotic 12*14*5mm (CCN-00001) Trial Lordotic 14*16*8mm (CCN-00012) Trial Lordotic 14*16*9mm (CCN-00013) Trial Anatomic 12*14*6mm (CCN-00018) Trial Anatomic 12*14*5mm (CCN-00017) Trial Lordotic 12*14*9mm (CCN-00005) Trial Lordotic dual 14*16*7-8mm Trial Anatomic 14*16*11mm (CCN-00031 Trial Anatomic dual 14*16*7-8mm Trial Anatomic dual 12*14*9-10mm Trial Anatomic dual 14*16*11-12mm Trial Lordotic 14*16*10mm (CCN-00014) Trial Lordotic 12*14*12mm (CCN-00008) Trial Anatomic 14*16*10mm (CCN-00030) Trial Lordotic 12*14*8mm (CCN-00004) Cervical Cage impactor (CCN-00052) Cervical Cage bone impactor (CCN-00053) Trial Anatomic 14*16*8mm (CCN-00028) Bone Curette(5mm) (END-CU03M) Cervical Cage holder (CCN-00051) Trial Anatomic 14*16*7mm (CCN-00027) Serial Dilator 3 (END-SD003) Trial Lordotic 12*14*7mm (CCN-00003) Trial Lordotic 12*14*10mm (CCN-00006) Trial Lordotic dual 12*14*11-12mm Cervical Cage Container (CCT-00001) Trial Anatomic 12*14*12mm (CCN-00024) Trial Lordotic dual 12*14*7-8mm UV Retractor(100mm) (END-WT100) Serial Dilator 2 (END-SD002) Spinal Cord Retractor Straight (END-SCRS1) Curved Kerrison 3mm (END-CK03M) Rotator Kerrison Curved Head(3mm) (END-RKCH3) UV Retractor(70mm) (END-WT070) Indian Knife (END-DK001) CCN-00006 (AC.2094) ACDF Trial (Lordotic) L12 x W14 x A7 x H10 Boomerang Curette(3mm) (END-CUB3M) CCN-00012 (AC.2108) ACDF Trial (Lordotic) L14 x W14 x A7 x H8 UV Retractor(60mm) (END-WT060) CCN-00001 (AC.2089) ACDF Trial (Lordotic) L12 x W14 x A7 x H5 Pedicle Chisel(5mm) (END-OTP5M) Mallet (END-MA001) Trial Anatomic 14*16*12mm (CCN-00032) Trial Anatomic dual 14*16*9-10mm Trial Anatomic 14*16*5mm (CCN-00025) CCN-00013 (AC.2109) ACDF Trial (Lordotic) L14 x W14 x A7 x H9 CCN-00005(AC.2093) ACDF Trial (Lordotic) L12 x W14 x A7 x H9 Rotator Kerrison Head(2mm) (END-RKSH2) UV Retractor(90mm) (END-WT090) Hockey Chisel(Left 5mm) (END-OTL5M) Trial Anatomic dual 12*14*5-6mm Trial Anatomic 12*14*9mm (CCN-00021) Trial Lordotic dual 12*14*5-6mm Trial Lordotic dual 14*16*9-10mm Trial Anatomic 12*14*7mm (CCN-00019) Trial Lordotic 12*14*11mm (CCN-00007) CCN-00011 (AC.2107) ACDF Trial (Lordotic) L14 x W14 x A7 x H7 UV Retractor(80mm) (END-WT080) Serial Dilator 4 (END-SD004) CCN-00010 (AC.2106) ACDF Trial (Lordotic) L14 x W14 x A7 x H6 Trial Lordotic dual 14*16*5-6mm Trial Anatomic 14*16*9mm (CCN-00029) Trial Anatomic dual 12*14*11-12mm CCN-00009 (AC.2105) ACDF Trial (Lordotic) L14 x W14 x A7 x H5 Bone Curette(5mm) (END-CU06M) Bone Curette(3mm) (END-CU05M) Cervical Cage Lordotic Implant Caddy (CNR-00002) Trial Anatomic 12*14*10mm (CCN-00022) Trial Lordotic 14*16*5mm (CCN-00009) Trial Lordotic 12*14*6mm (CCN-00002) Trial Anatomic 12*14*8mm (CCN-00020) Trial Anatomic 12*14*11mm (CCN-00023) Trial Anatomic 14*16*6mm (CCN-00026) Freer (END-PF001) Spinal Cord Retractor Curved (END-SCRC1) CERVICAL CAGE IMPLANTS CONTAINER (CCT-00001, AICN-1005-0001, and others) Trial Lordotic 14*16*6mm (CCN-00010) Trial Lordotic 14*16*12mm (CCN-00016) BESS Tray with Lid (END-TR001) Rotator Kerrison Head(3mm) (END-RKSH3) Trial Lordotic 14*16*11mm (CCN-00015) CCN-00052 (AC300) Cervical Cage impactor CCN-00049 (AC401) Cage holder inner shaft

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198