Orthohelix Surgical Designs Inc

11 dispositifs dans la base de données

  • Modèle / numéro de série
    Model # MSD-010-55-060S
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Product was delivered to: CA, CO, GA, NM, NY, OH, VA & WA.
  • Description du dispositif
    MaxTorque Cannulated Screw Model # MSD-010-55-060S
  • Modèle / numéro de série
    Model Number(s): MXM-901; Tray codes affected: LAQ, LAV, LCL, LCN, LBZ, LCA, LBV, LCU, LAR, LBJ, LBT, LDE, LDG, LBL, LCD, LBI, LCI, LBQ, LCV, LBK, LBC, LCW, LCB, LDH, LBM, LCM, LCK, LDB, LBS, LCE, LDD, LDF, LAX, LDI, LAP, LBH, LBP, LAO, LBB, LBE, LBX, LCH, LAT, LAS, LCR, LDC, LAW, LCJ, LDJ, LCZ, LAU, LBF, LCQ, LBN, LCP, LCX, LBU, LBW, LBY, LCT, LCY, LAY, LAZ, LBA, LBD, LBG, LBO, LBR, LCC, LCF, LCG, LCS, LDA, LDM, LDN, LDO, LDP, LDQ, LDR, LDS, LDT, LDU & LDK.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    USA Nationwide Distribution including the states of: AR, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI & WY.
  • Description du dispositif
    Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901, || Product Usage: The Mini MaxLock Extreme Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. Surgical Case and Tray Delivery System used to house plating and screw orthopedic implant system and instrumentation.
  • Modèle / numéro de série
    Lot # 1364, 1731, 1862, Model # VAR-031-35-10, Model # VAR-031-35-12, Model # VAR-031-35-14, Model # VAR-031-35-16, Model # VAR-031-35-18, Model # VAR-031-35-20, Model # VAR-031-35-22, Model # VAR-031-35-24, Model #, VAR-031-35-26, Model # VAR-031-35-28, Model # VAR-031-35-30 & Lot # 1365011, 1365012, Model #, MXL-032-35 and Model # VAR-032-35
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution (USA) - including the states of: CA, CO, CT, FL, GA, IA, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, SD, TN, TX, UT, VA, WA, WI and WY.
  • Description du dispositif
    MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. || Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.
  • Modèle / numéro de série
    HSC-056-32-1067051
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA, and WI.
  • Description du dispositif
    OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS || The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
  • Modèle / numéro de série
    HSC-056-38-1067061
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA, and WI.
  • Description du dispositif
    OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS || The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
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En savoir plus sur les données ici

  • Adresse du fabricant
    Orthohelix Surgical Designs Inc, 1815 W Market Street, Suite 205, Akron OH 44313
  • Source
    USFDA
  • Adresse du fabricant
    OrthoHelix Surgical Designs Inc, 1815 W Market St Ste 205, Akron OH 44313-7018
  • Source
    USFDA
  • Adresse du fabricant
    Orthohelix Surgical Designs Inc, 1065 Medina Rd Ste 500, Medina OH 44256-5376
  • Société-mère du fabricant (2017)
  • Source
    USFDA