FDA.reportPublic FDA data

Aptitude Anterior Cervical Plate System

Primary DI
B648C16401260
Brand
Aptitude Anterior Cervical Plate System
Company
CURITEVA, INC.
Model
C164-01-26
Device description
Midline Anterior Cervical Plate, One-Level, 26mm
Published
2019-01-04
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
K181549000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181549000Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)Curiteva, LLC2018-08-03KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B648C16401260PrimaryHIBCC0

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
Length26Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (877) 928-7483support@curiteva.com

Regulatory Flags#

DUNS number
074575332
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B648C284302412121Inspire Lumbar Interbody Fusion SystemC284-302412-122026-07-06
B648C284302412141Inspire Lumbar Interbody Fusion SystemC284-302414-122026-07-06
B648C284302412161Inspire Lumbar Interbody Fusion SystemC284-302416-122026-07-06
B648C28430241861Inspire Lumbar Interbody Fusion SystemC284-302418-62026-07-06
B648C29515000Savant Lumbar Interbody Fusion SystemC295-15002026-07-06
B648C4452100Savant Lumbar Interbody Fusion SystemC445-2102024-01-04
B648C4452200Savant Lumbar Interbody Fusion SystemC445-2202024-01-04
B648C2853000Inspire Lumbar Interbody Fusion SystemC285-3002026-01-09
B648C3051500Savant Lumbar Interbody Fusion SystemC305-1502026-01-09
B648C505420450Prodigy Pedicle Screw SystemC505-420-452026-01-09
B648C505420550Prodigy Pedicle Screw SystemC505-420-552026-01-09
B648C505420650Prodigy Pedicle Screw SystemC505-420-652026-01-09
B648C6151252750SI-LUTION Sacroiliac Joint Fusion SystemC615-125-2752026-01-09
B648C615125275E0SI-LUTION Sacroiliac Joint Fusion SystemC615-125-275E2026-01-09
B648C6151253000SI-LUTION Sacroiliac Joint Fusion SystemC615-125-3002026-01-09
B648C615125300E0SI-LUTION Sacroiliac Joint Fusion SystemC615-125-300E2026-01-09
B648C6151253250SI-LUTION Sacroiliac Joint Fusion SystemC615-125-3252026-01-09
B648C615125325E0SI-LUTION Sacroiliac Joint Fusion SystemC615-125-325E2026-01-09
B648C72540281420T0Inspire®SA 3D Printed Trabecular PEEK™ with HAFUSE®C725-402814-20T2026-01-09
B648C11551560Acumen Thoracolumbar Plate SystemC1155-1562026-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986492791CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
08809986492807CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
08809986492814CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
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