FDA.reportPublic FDA data

Cross Connector, Medium

Primary DI
M739247137520
Brand
Cross Connector, Medium
Company
CAPTIVA SPINE, INC.
Model
2471-3752
Device description
Cross Connector, Medium
Published
2017-08-08
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
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
K120292000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120292000CAPLOX II PEDICLE SCREW SYSTEMCaptiva Spine, Inc.2012-04-13MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M739247137520PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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
M739153997700Cross Connector Driver15399-77002026-10-23
M739153998800Cross Connector Counter Torque15399-88002026-10-23
M739243501000Blade Dilator24350-10002026-10-23
M739243502000Parallel Guide24350-20002026-10-23
M739243503000In-Line Handle24350-30002026-10-23
M739243504000Tissue Dilator24350-40002026-10-23
M739243505000Tissue Protector24350-50002026-10-23
M739243506000Adjustable Parallel Guide24350-60002026-10-23
M739243507000Impaction Sleeve24350-70002026-10-23
M739243508000Self-Feeding Drill24350-80002026-10-23
M739243509000Implant Filling Tube24350-90002026-10-23
M739243511000Plunger Rod24351-10002026-10-23
M739243512000Cannulated Drill, 7mm24351-20002026-10-23
M7399830151066mm Cannulated Drill98301-51062026-10-23
M7399830151077mm Cannulated Drill98301-51072026-10-23
M7399830151088mm Cannulated Drill98301-51082026-10-23
M7399830151099mm Cannulated Drill98301-51092026-10-23
M73998301511010mm Cannulated Drill98301-51102026-10-23
M73998301511111mm Cannulated Drill98301-51112026-10-23
M73998301511212mm Cannulated Drill98301-51122026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935677XL AdaptorPREMIA SPINE LTDMNH2026-10-20
07290115935677XL AdaptorPREMIA SPINE LTDMNI2026-10-20
07290115935905XL Screwdriver CMPREMIA SPINE LTDMNH2026-10-20
07290115935905XL Screwdriver CMPREMIA SPINE LTDMNI2026-10-20
07290115935912Screwdriver CMPREMIA SPINE LTDMNH2026-10-20
07290115935912Screwdriver CMPREMIA SPINE LTDMNI2026-10-20
07290115935929Tube for K-wire over a k-wire technique 470mm (Nitinol)PREMIA SPINE LTDMNI2026-10-20
07290115935929Tube for K-wire over a k-wire technique 470mm (Nitinol)PREMIA SPINE LTDMNH2026-10-20
07290115935936Tube for XL K-Wire 450mmPREMIA SPINE LTDMNI2026-10-20
07290115935936Tube for XL K-Wire 450mmPREMIA SPINE LTDMNH2026-10-20
07290115935943Tube for K-Wires of 470mmPREMIA SPINE LTDMNH2026-10-20
07290115935943Tube for K-Wires of 470mmPREMIA SPINE LTDMNI2026-10-20
07290115935950Tube for K-Wires up to 340mmPREMIA SPINE LTDMNH2026-10-20
07290115935950Tube for K-Wires up to 340mmPREMIA SPINE LTDMNI2026-10-20
07290115932874Cannulated Screwdriver inner shaftPREMIA SPINE LTDMNH2026-10-18
07290115932874Cannulated Screwdriver inner shaftPREMIA SPINE LTDMNI2026-10-18
07290115932881Cannulated Screwdriver Handle AssyPREMIA SPINE LTDMNH2026-10-18
07290115932881Cannulated Screwdriver Handle AssyPREMIA SPINE LTDMNI2026-10-18
M697X07300251Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07300251Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X073825100DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X073825100DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382560DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382560DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382565DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382565DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382570DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382570DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382575DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382575DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14