FDA.reportPublic FDA data

MIS Curved Rod, Ø5.5 x 30mm

Primary DI
M739161554030
Brand
MIS Curved Rod, Ø5.5 x 30mm
Company
CAPTIVA SPINE, INC.
Model
16155-4030
Device description
MIS Curved Rod
Published
2025-05-20
Public version status
New
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
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122332000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122332000TOWERLOX PEDICLE SCREW SYSTEMCaptiva Spine2012-10-16MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M739161554030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic instrument surgical connectorA small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). 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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00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
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