FDA.reportPublic FDA data

Oryx™

Primary DI
M711AP4580
Brand
Oryx™
Company
INNO Holdings, Inc.
Model
AP458
Catalog number
AP458
Device description
Ti 6Al 4V (ELI)
Published
2020-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192049000Oryx Cervical Plate SystemInnovasis, Inc.2019-11-08KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711AP4580PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length58Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
801-261-2236info@innovasis.com

Regulatory Flags#

DUNS number
141620464
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M711BTA2020Vector™ Pedicle Screw SystemBTA-2022026-06-05
M711LS7490Vector™ Pedicle Screw SystemLS-7492026-06-05
M711511410070Endeavor™ Stand-Alone Cervical51-1410072026-05-31
M711511410120Endeavor™ Stand-Alone Cervical51-1410122026-05-31
M711511411070Endeavor™ Stand-Alone Cervical51-1411072026-05-31
M711511411120Endeavor™ Stand-Alone Cervical51-1411122026-05-31
M711511412070Endeavor™ Stand-Alone Cervical51-1412072026-05-31
M711511412120Endeavor™ Stand-Alone Cervical51-1412122026-05-31
M711511606070Endeavor™ Stand-Alone Cervical51-1606072026-05-31
M711511607070Endeavor™ Stand-Alone Cervical51-1607072026-05-31
M711511607120Endeavor™ Stand-Alone Cervical51-1607122026-05-31
M711511608070Endeavor™ Stand-Alone Cervical51-1608072026-05-31
M711511608120Endeavor™ Stand-Alone Cervical51-1608122026-05-31
M711511609070Endeavor™ Stand-Alone Cervical51-1609072026-05-31
M711511609120Endeavor™ Stand-Alone Cervical51-1609122026-05-31
M711511610070Endeavor™ Stand-Alone Cervical51-1610072026-05-31
M711511610120Endeavor™ Stand-Alone Cervical51-1610122026-05-31
M711511611070Endeavor™ Stand-Alone Cervical51-1611072026-05-31
M711511611120Endeavor™ Stand-Alone Cervical51-1611122026-05-31
M711511612070Endeavor™ Stand-Alone Cervical51-1612072026-05-31

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Primary DI, Brand, Company table
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00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-08-02
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00840493425382RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425399RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425405RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425412RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
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00840493425443RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
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00840493425467RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425474RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28