FDA.reportPublic FDA data

Rod Pusher (Cannulated)

Primary DI
M739223170110
Brand
Rod Pusher (Cannulated)
Company
CAPTIVA SPINE, INC.
Model
2231-7011
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M739223170110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic rod reducerA heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
836975784
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M739131064012Variable Screw, Self-Tapping, 4.0mm x 12mm13106-40122015-10-30
M739131064014Variable Screw, Self-Tapping, 4.0mm x 14mm13106-40142015-10-30
M739131064016Variable Screw, Self-Tapping, 4.0mm x 16mm13106-40162015-10-30
M739131064018Variable Screw, Self-Tapping, 4.0mm x 18mm13106-40182015-10-30
M739131164012Fixed Screw, Self-Tapping, 4.0mm x 12mm13116-40122015-10-30
M739131164014Fixed Screw, Self-Tapping, 4.0mm x 14mm13116-40142015-10-30
M739131164016Fixed Screw, Self-Tapping, 4.0mm x 16mm13116-40162015-10-30
M739131164018Fixed Screw, Self-Tapping, 4.0mm x 18mm13116-40182015-10-30
M73924712832Cross Connector, XSmall2471-28322015-10-30
M73924713139Cross Connector, Small2471-31392015-10-30
M73924713752Cross Connector, Medium2471-37522015-10-30
M73924714963Cross Connector, Medium-Large2471-49632015-10-30
M73924714975Cross Connector, Large2471-49752015-10-30
M739CP300201-Level Cervical Plates, 20 mmCP300202015-10-30
M739CP3002001-Level Cervical Plates, 20 mmCP300202017-08-11
M739CP300221-Level Cervical Plates, 22 mmCP300222015-08-28
M739CP3002201-Level Cervical Plates, 22 mmCP300222017-08-11
M739CP300241-Level Cervical Plates, 24 mmCP300242015-08-28
M739CP3002401-Level Cervical Plates, 24 mmCP300242017-08-11
M739CP300261-Level Cervical Plates, 26 mmCP300262015-08-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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