Innovasis, Inc.
Innovasis, Inc. holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2025, with 7 FDA device recalls on record.
Top product codes for Innovasis, Inc.
FDA recalls by Innovasis, Inc.
- Z-2859-2026 — Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
- Z-3163-2024 — 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.
- Z-2062-2020 — 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.
- Z-0644-2018 — 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:
- Z-2153-2017 — 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.
- Z-0662-2016 — 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.
- Z-2067-2014 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Innovasis, Inc.
- K251073 — Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
- K250182 — Innovasis Navigation Instruments
- K241276 — Vector Pedicle Screw System
- K231899 — HAtetracell-C Titanium Cervical IBF System
- K223511 — Excella Navigation Instruments
- K223510 — Matrix HA Fusion Porous Cervical IBF System
- K220875 — HAcancellous PEEK-C Porous HA PEEK Cervical IBF System
- K212967 — AxTiHA Stand-Alone ALIF System
- K201614 — TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
- K200874 — TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
- K192049 — Oryx Cervical Plate System
- K192354 — Innovasis Gibralt Spine System
- K183064 — TxTi IBF System
- K182139 — AXTi Titanium Stand-Alone ALIF System
- K190684 — LxHA PEEK Lateral IBF System
- K181115 — CxHA PEEK Cervical IBF System
- K181063 — Kestrel Buttress Plate System
- K180078 — Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
- K162236 — Ax Stand-Alone ALIF System
- K162143 — FixxSure® X-Link
- K151785 — Px HA PEEK IBF System
- K150500 — Px PEEK IBF System
- K141644 — INNOVASIS CRANIAL SYSTEM
- K132765 — PFX SPINOUS PROCESS FIXATION SYSTEM
- K140238 — EXCELLA III-D SPINAL DEFORMITY SYSTEM
- K132991 — C-BOX PEEK CERVICAL IBF
- K121581 — BOX PEEK VBR SYSTEM,
- K102248 — EXCELLA II SPINAL SYSTEM MODEL EC2-00
- K071921 — INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)
- K062151 — BOX PEEK VBR SYSTEM
- K061147 — OPTERYX ANTERIOR CERVICAL PLATE SYSTEM
- K042143 — EXCELLA-M SPINAL SYSTEM
- K041583 — PEEK CEMENT RESTRICTOR X-BOX
Data sourced from openFDA. This site is unofficial and independent of the FDA.