FDA.reportPublic FDA data

Canaveral®

Primary DI
B1830123550400
Brand
Canaveral®
Company
FLOSPINE LLC
Model
Canaveral®
Catalog number
01-2355-040
Device description
5.5mm Curved Fixed MIS Rod, Ti Alloy 40mm
Published
2025-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

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
K141850000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141850000FLOSPINE PEDICLE SCREW SYSTEMFlospine2014-10-27NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1830123550400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(561)705-3080info@flospine.com

Regulatory Flags#

DUNS number
042993143
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B1830802450120Panama™Panama™08-0245-0122021-09-01
B1830802450140Panama™Panama™08-0245-0142021-09-01
B1830802450160Panama™Panama™08-0245-0162021-09-01
B1830802450180Panama™Panama™08-0245-0182021-09-01
B1830802450200Panama™Panama™08-0245-0202021-09-01
B1830803400120Panama™Panama™08-0340-0122021-09-01
B1830803400140Panama™Panama™08-0340-0142021-09-01
B1830803400160Panama™Panama™08-0340-0162021-09-01
B1830803400180Panama™Panama™08-0340-0182021-09-01
B1830803400200Panama™Panama™08-0340-0202021-09-01
B1830803450120Panama™Panama™08-0345-0122021-09-01
B1830803450140Panama™Panama™08-0345-0142021-09-01
B1830803450160Panama™Panama™08-0345-0162021-09-01
B1830803450180Panama™Panama™08-0345-0182021-09-01
B1830803450200Panama™Panama™08-0345-0202021-09-01
B1830804400120Panama™Panama™08-0440-0122021-09-01
B1830804400140Panama™Panama™08-0440-0142021-09-01
B1830804400160Panama™Panama™08-0440-0162021-09-01
B1830804400180Panama™Panama™08-0440-0182021-09-01
B1830804400200Panama™Panama™08-0440-0202021-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857037953EVEREST® Spinal SystemVB Spine LLCMNH2026-06-11
10888857037953EVEREST® Spinal SystemVB Spine LLCMNI2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCMNI2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCMNH2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857008724EVEREST® Spinal SystemVB Spine LLCMNI2016-03-10
10888857008724EVEREST® Spinal SystemVB Spine LLCMNH2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001497DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24