Innovasis, Inc

4 devices in the database

  • Model / Serial
    E2S47525 Lot 1301 and E2S47535 Lot 1301
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
  • Product Description
    Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
  • Model / Serial
    Catalog/Part No.: E2S8530, E2S8535, E2S8540, E2S8545, E2S8550, E2S8555, E2S8560 with Lot Number: 1101 and Catalog/Part No.: E28540, E28545 with Lot Number: 1201. Each of these parts is engraved with part number and lot number.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    United States
  • Product Description
    Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:
  • Model / Serial
    Lot #1601
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of  CA, UT, ID, TX, OH, and MN.
  • Product Description
    Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. || Product Usage: || 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx¿ Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae.
  • Model / Serial
    Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in US -- CA; KS; OH; & TX.
  • Product Description
    Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 || Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. || Intended for use in the non-cervical area of the spine.