FDA.reportPublic FDA data

ORIA Zenith® Cervical Plate System

Primary DI
00840996130813
Brand
ORIA Zenith® Cervical Plate System
Company
Choice Spine, LP
Model
F070-5015
Device description
ZENITH,PLATE BENDER
Published
2016-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXWBENDER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001535000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001535000ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATIONOrtho Tec, LLC2001-03-20KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840996130813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840996130813008409961308138409961308130840996130813

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).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(865)246-3333info@choicespine.net

Regulatory Flags#

DUNS number
078293017
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810211101256THUNDERBOLTM070-02312026-02-13
00840996176552BOOMERANGBT20-D45132026-01-15
00840996176569BOOMERANGBT20-D45152026-01-15
00840996176576BoomerangBT20-D45172026-01-15
00840996176583BOOMERANGB070-00002026-01-15
00840996176590BOOMERANGB070-D0102026-01-15
00840996176606BoomerangB070-00012026-01-15
00840996182119HARRIER-SA Lumbar Interbody SystemY070-00432024-02-26
00840996150682Acapella One05-099-05-14052024-02-24
00840996150699Acapella One05-099-05-14062024-02-24
00840996150705Acapella One05-099-05-14072024-02-24
00840996150712Acapella One05-099-05-14082024-02-24
00840996150729Acapella One05-099-05-14092024-02-24
00840996150736Acapella One05-099-05-14102024-02-24
00840996150743Acapella One05-099-05-14112024-02-24
00840996150750Acapella One05-099-05-14122024-02-24
00840996150767Acapella One05-099-05-16052024-02-24
00840996150774Acapella One05-099-05-16062024-02-24
00840996150781Acapella One05-099-05-16072024-02-24
00840996150798Acapella One05-099-05-16082024-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118144928LEVEL ONE EXTREMITYKLS-Martin L.P.HXW2026-05-25
03662663108386Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCHXW2026-02-11
00840536800237Response Spine SystemORTHOPEDIATRICS CORP.HXW2026-01-15
00840180543283General InstrumentsALPHATEC SPINE, INC.HXW2025-12-31
00840180543290General InstrumentsALPHATEC SPINE, INC.HXW2025-12-31
10889981095987GeneralSeaspine Orthopedics CorporationHXW2025-12-19
03662663261869BacFix Ti Spinal Fixation SystemHighridge Medical, LLCHXW2025-12-18
00840194418140PediflexORTHOPEDIATRICS CORP.HXW2025-12-11
00840493413907RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413914RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413921RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413938RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413945RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00199150044375Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2025-11-24
00199150044382Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2025-11-24
03662663153379Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663153386Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663153393Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663153409Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663191784Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663214872Vital Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663214889Vital Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663214896Vital Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663146227Gallery Laminoplasty Fixation SystemHighridge Medical, LLCHXW2025-11-15
03662663113410Virage OCT Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-14
03662663131995Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-14
03662663132008Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-14
03662663136785Polaris 4.75 Deformity SystemHighridge Medical, LLCHXW2025-11-14
03662663136792Polaris 4.75 Deformity SystemHighridge Medical, LLCHXW2025-11-14
03662663136808Polaris 4.75 Deformity SystemHighridge Medical, LLCHXW2025-11-14