FDA.reportPublic FDA data

PRADO™ Lumbar Interbody Fusion System

Primary DI
G616RTFH101028150
Brand
PRADO™ Lumbar Interbody Fusion System
Company
Pt. Solutions, LLC
Model
R-TFH-101028-15
Catalog number
R-TFH-101028-15
Device description
NON-STERILE PRADO™ T HA PEEK IBF, 10MM H X 10MM W x 28MM L, 15°L
Published
2026-04-10
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G616RTFH101028150PrimaryHIBCC0

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
Angle15degree
Height10Millimeter
Length28Millimeter
Width10Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119209551
Device count
1
Lot or batch
true
Sterilization required before use
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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