Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Innovasis with 35 510(k) clearances and 7 device recalls. The most recent is a device recall dated May 22, 2026: Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 22, 2026 | Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw SystemClass II · Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/s | Device recalls |
| Sep 25, 2025 | Endeavor™ Stand-Alone Cervical IBF SystemK250076 · OVE | 510(k) clearances |
| Jul 23, 2025 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)K251073 · OLO | 510(k) clearances |
| Mar 24, 2025 | AxTiHA® Stand-Alone ALIF SystemK250603 · OVD | 510(k) clearances |
| Mar 24, 2025 | Innovasis Navigation InstrumentsK250182 · OLO | 510(k) clearances |
| Aug 14, 2024 | TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intendedClass II · Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. | Device recalls |
| May 20, 2024 | Vector™ Pedicle Screw SystemK241276 · NKB | 510(k) clearances |
| Oct 17, 2023 | HAtetracell™-C Titanium Cervical IBF SystemK231899 · ODP | 510(k) clearances |
| May 2, 2023 | Excella Navigation InstrumentsK223511 · OLO | 510(k) clearances |
| Dec 12, 2022 | Matrix HA Fusion Porous Cervical IBF SystemK223510 · ODP | 510(k) clearances |
| Apr 7, 2020 | Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intClass II · Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy location l | Device recalls |
| Jan 8, 2018 | Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and sClass II · Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage. | Device recalls |
| May 5, 2017 | Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mmClass II · Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14). | Device recalls |
| Dec 7, 2015 | 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-sealClass II · Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels. | Device recalls |
| Jul 7, 2014 | Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastiClass II · Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
