INNOVASIS, INC.

FDA Device Registration & Listing · Millcreek, UT, US · Registration 3004719693

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004719693
FEI Number
3004719693
Entity Name
INNOVASIS, INC.
City/State/Country
Millcreek, UT, US
Establishment Address
614 E 3900 S, Millcreek, UT 84107, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Inno Holdings Inc. (Owner Number: 10094493)
Owner / Operator Contact Address
614 E 3900 S, Salt Lake City, UT 84107, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K162143
PMA Number
N/A

All Registered Proprietary Names

T-Box PEEK VBR System X-Box PEEK VBR System TruView Light Cable Innovasis Navigation Instruments Vector M-S Navigation Instruments CxHA PEEK Cervical IBF System SpineWorks FixxSure X-Link Endeavor Stand-Alone Cervical IBF System Kestrel Buttress Plate System SpineWorks Anterior Lumbar Device SpineWorks ALD Neuro & Craniofacial Fixation System Excella II Spinal System Excella III-D Spinal Deformity System Excella MIS Spinal System Excella 3 Spinal System Opteryx Cervical Plate System Excella M-S Navigation Instruments Innovasis Navigation Instruments Gibralt Spine System Gibralt Posterior Cervical Spine System Vector G-E Navigation Instruments Innovasis Navigation Instruments Excella G-E Navigation Instruments PxHA PEEK IBF System Excella-P Spinal System Excella Spinal System Innovasis Disc Prep Excella-M Spinal System Neuro & Craniofacial Fixation System SpineWorks Stansion Matrix Pedicle Subtraction Osteotomy Set PSO AxTiHA Stand-Alone ALIF System TxTiHA IBF System HAtetracell-C Titanium Cervical IBF System Oryx Cervical Plate System Excella III-D Spinal Deformity System PxHA PEEK IBF System Px PEEK IBF System TxHA PEEK IBF System LxHA PEEK Lateral IBF System ICS Innovasis Cranial System TruView Lateral Retractor System TruView Lateral Access System AxHA Stand-Alone ALIF System SpineWorks FixxSure X-Link

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-12-03
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2025-12-03
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-03
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-12-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-03
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-12-03
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-12-03
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-12-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-03
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-03
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-03
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-03
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-12-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-03
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-12-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-03
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2025-12-03
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-03
HBW Fastener, Plate, Cranioplasty Neurology Class 2 882.5360 2025-12-03
GXR Cover, Burr Hole Neurology Class 2 882.5250 2025-12-03
GWO Plate, Cranioplasty, Preformed, Alterable Neurology Class 2 882.5320 2025-12-03
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-12-03
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2025-12-03
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-12-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-12-03
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-12-03
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-03
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-12-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-12-03
GXR Cover, Burr Hole Neurology Class 2 882.5250 2025-12-03
HBW Fastener, Plate, Cranioplasty Neurology Class 2 882.5360 2025-12-03
GWO Plate, Cranioplasty, Preformed, Alterable Neurology Class 2 882.5320 2025-12-03
GAD Retractor General, Plastic Surgery Class 1 878.4800 2025-12-03
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-12-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-03

Official Correspondent

Michael Thomas

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Inno Holdings Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K041888 Signus Medizintechnik GmbH CURVED PEEK TETRIS SPINAL IMPLANT 2004-08-10
K211892 Arftx Medical, LLC ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) 2022-10-06
K070082 Vertebration,Inc XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY 2007-04-20
K051027 Surgicraft , Ltd. STALIF TT 2005-06-29
K901491 Cuda Products Co. CUDA SURGICAL LIGHT 1990-06-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004719693. Last updated year: 2026. Please use registration number 3004719693 when referencing this establishment in official correspondence.
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