FDA.reportPublic FDA data

Prado C (HA)

Primary DI
G616CFH101614140
Brand
Prado C (HA)
Company
Pt. Solutions, LLC
Model
CFH101614-14
Catalog number
CFH101614-14
Device description
HA PEEK Cervical Lordotic Intervertebral Body Fusion Device
Published
2024-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G616CFH101614140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle14degree
Height10Millimeter
Length14Millimeter
Width16Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119209551
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G616RAFS102433060PRADO™ Lumbar Interbody Fusion SystemR-AFS-102433-06R-AFS-102433-062026-04-17
G616RAFS102433120PRADO™ Lumbar Interbody Fusion SystemR-AFS-102433-12R-AFS-102433-122026-04-17
G616RAFS102636060PRADO™ Lumbar Interbody Fusion SystemR-AFS-102636-06R-AFS-102636-062026-04-17
G616RAFS102636110PRADO™ Lumbar Interbody Fusion SystemR-AFS-102636-11AR-AFS-102636-11A2026-04-17
G616RAFS102636120PRADO™ Lumbar Interbody Fusion SystemR-AFS-102636-12R-AFS-102636-122026-04-17
G616RAFS102839060PRADO™ Lumbar Interbody Fusion SystemR-AFS-102839-06R-AFS-102839-062026-04-17
G616RAFS122433060PRADO™ Lumbar Interbody Fusion SystemR-AFS-122433-06R-AFS-122433-062026-04-17
G616RAFS122433120PRADO™ Lumbar Interbody Fusion SystemR-AFS-122433-12R-AFS-122433-122026-04-17
G616RAFS122636060PRADO™ Lumbar Interbody Fusion SystemR-AFS-122636-06R-AFS-122636-062026-04-17
G616RAFS122636110PRADO™ Lumbar Interbody Fusion SystemR-AFS-122636-11AR-AFS-122636-11A2026-04-17
G616RAFS122636120PRADO™ Lumbar Interbody Fusion SystemR-AFS-122636-12R-AFS-122636-122026-04-17
G616RAFS122839060PRADO™ Lumbar Interbody Fusion SystemR-AFS-122839-06R-AFS-122839-062026-04-17
G616RAFS142433060PRADO™ Lumbar Interbody Fusion SystemR-AFS-142433-06R-AFS-142433-062026-04-17
G616RAFS142433120PRADO™ Lumbar Interbody Fusion SystemR-AFS-142433-12R-AFS-142433-122026-04-17
G616RAFS142636060PRADO™ Lumbar Interbody Fusion SystemR-AFS-142636-06R-AFS-142636-062026-04-17
G616RAFS142636110PRADO™ Lumbar Interbody Fusion SystemR-AFS-142636-11AR-AFS-142636-11A2026-04-17
G616RAFS142636120PRADO™ Lumbar Interbody Fusion SystemR-AFS-142636-12R-AFS-142636-122026-04-17
G616RAFS142839060PRADO™ Lumbar Interbody Fusion SystemR-AFS-142839-06R-AFS-142839-062026-04-17
G616RAFS162433060PRADO™ Lumbar Interbody Fusion SystemR-AFS-162433-06R-AFS-162433-062026-04-17
G616RAFS162433120PRADO™ Lumbar Interbody Fusion SystemR-AFS-162433-12R-AFS-162433-122026-04-17

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