Orthohelix Surgical Designs Inc

11 devices in the database

  • Model / Serial
    CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: to the states of GA and MO.
  • Product Description
    CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011
  • Model / Serial
    CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: to the states of GA and MO.
  • Product Description
    CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021
  • Model / Serial
    CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: to the states of GA and MO.
  • Product Description
    CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031
  • Model / Serial
    Model #CSS-QA-Adapter Lot #: GB759, GB-924, 1014001 & 1101011
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: CA, CO, FL, GA, IL, KY, MD, MI, MO, MS, NC, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA , and WI.
  • Product Description
    Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH || The intended use: Used to stabilize and aid in the fixation of fractures, fusions, and osteotomies.
  • Model / Serial
    Lot NG808, Lot NG861, & Lot 1048031.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- CO, OH, PA, SD, TX & VA.
  • Product Description
    Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38. || Used to drill or cut bone prior to implantation of screws
6 more

3 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Orthohelix Surgical Designs Inc, 1815 W Market Street, Suite 205, Akron OH 44313
  • Source
    USFDA
  • Manufacturer Address
    OrthoHelix Surgical Designs Inc, 1815 W Market St Ste 205, Akron OH 44313-7018
  • Source
    USFDA
  • Manufacturer Address
    Orthohelix Surgical Designs Inc, 1065 Medina Rd Ste 500, Medina OH 44256-5376
  • Manufacturer Parent Company (2017)
  • Source
    USFDA