36 results
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37ms
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Sources: EU EUDAMED, US FDA
INNOVASIS, INC.
FDA registration
INNOVASIS, INC.·20 products·🇺🇸 United States
OPTERYX CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·INNOVASIS, INC.·Product code KWQ·November 29, 2010
OPTERYX
FDA Adverse Event
Injury
·INNOVASIS, INC.·Product code KWQ·December 23, 2009
OPTERYX
FDA Adverse Event
Injury
·INNOVASIS, INC.·Product code KWQ·December 23, 2009
EXCELLA-P
FDA Adverse Event
Injury
·INNOVASIS, INC.·Product code MNI·April 25, 2009
EXCELLA-P
FDA Adverse Event
Injury
·INNOVASIS, INC.·Product code MNI·April 25, 2009
EXCELLA-P
FDA Adverse Event
Injury
·INNOVASIS, INC.·Product code MNI·April 24, 2009
INNOVASIS AXHA STAND ALONE ALIF
FDA Adverse Event
Injury
·INNOVASIS, INC·Product code OVD·August 31, 2020
TX IBF SYSTEM
FDA Adverse Event
Malfunction
·INNOVASIS, INC.·Product code MAX·August 15, 2024
EXCELLA-P
FDA Adverse Event
Injury
·INNOVASIS, INC.·Product code MNI·September 5, 2008
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
FDA Adverse Event
Malfunction
·INNOVASIS INC.·Product code NKB·March 18, 2019
TXTIHA IBF SYSTEM
FDA Adverse Event
Injury
·INNOVASIS, INC.·Product code MAX·November 29, 2022
EXCELLA III-D SPINAL DEFORMITY SYSTEM
FDA Adverse Event
Injury
·INNOVASIS, INC.·Product code NKB·December 7, 2022
AXHA PEEK IBF SYSTEM
FDA Adverse Event
Injury
·INNOVASIS, INC·Product code MAX·March 8, 2021
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.
FDA Recall
Terminated
·Innovasis, Inc·Product code KWQ·May 5, 2017
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.
FDA Recall
Terminated
·Innovasis, Inc·Product code NKB·July 7, 2014
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.
FDA Recall
Terminated
·Innovasis, Inc·Product code NKB·December 7, 2015
Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation.
FDA Recall
Terminated
·Innovasis, Inc·Product code KWQ·April 7, 2020
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:
FDA Recall
Terminated
·Innovasis, Inc·Product code NKB·January 8, 2018
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery. ii. TxTiHA The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.
FDA Recall
Open, Classified
·Innovasis, Inc·Product code MAX·August 14, 2024