TirboLOX-C Cervical IBFD

Primary DI
M7391810714090
Brand
TirboLOX-C Cervical IBFD
Company
CAPTIVA SPINE, INC.
Model
18107-1409
Device description
3D Cage - Lordotic (W)17.5 x (L)14 x (H)9mm
Published
2019-05-22
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

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181229000TirboLOX-C Cervical IBFDCaptiva Spine, Inc.2018-09-19ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7391810714090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fusion sphereA sterile implantable metal sphere used to stabilize interspinous processes from L3 to S1 to promote intervertebral body fusion. It is inserted into the disc space between two vertebral bodies, and is specifically designed to be used with a bone graft to hold the bones in alignment while they heal and fuse. The device is typically made of a high-grade medical cobalt-chrome (Co-Cr) or Cobalt-Chrome-Molybdenum (Co-Cr-Mo).

Contacts#

Phone, Email table
PhoneEmail
877-772-5571info@captivaspine.com

Regulatory Flags#

DUNS number
836975784
Device count
1
DM exempt
true
Lot or batch
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
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00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.ODP2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.ODP2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.ODP2026-06-05
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