FDA.reportPublic FDA data

CURE IVIEW

Primary DI
B167900002400
Brand
CURE IVIEW
Company
MEDITECH SPINE, LLC
Model
9-00002-40
Published
2022-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K180090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180090000Cure™ Lumbar Plate SystemMeditech Spine, LLC2018-04-23KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B167900002400PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
182698477
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B167900002250CURE IVIEW9-00002-252022-10-07
B167900002260CURE IVIEW9-00002-262022-10-07
B167900002270CURE IVIEW9-00002-272022-10-07
B167900002280CURE IVIEW9-00002-282022-10-07
B167900002290CURE IVIEW9-00002-292022-10-07
B167900002300CURE IVIEW9-00002-302022-10-07
B167900002310CURE IVIEW9-00002-312022-10-07
B167900002320CURE IVIEW9-00002-322022-10-07
B167900002330CURE IVIEW9-00002-332022-10-07
B167900002340CURE IVIEW9-00002-342022-10-07
B167900002350CURE IVIEW9-00002-352022-10-07
B167900002360CURE IVIEW9-00002-362022-10-07
B167900002370CURE IVIEW9-00002-372022-10-07
B167900002380CURE IVIEW9-00002-382022-10-07
B167900002390CURE IVIEW9-00002-392022-10-07
B167900002410CURE IVIEW9-00002-412022-10-07
B167900002420CURE IVIEW9-00002-422022-10-07
B167900002430CURE IVIEW9-00002-432022-10-07
B167900002440CURE IVIEW9-00002-442022-10-07
B167900002450CURE IVIEW9-00002-452022-10-07

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Primary DI, Brand, Company table
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00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424989RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424996RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493425009RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13