FDA.reportPublic FDA data

Canaveral®

Primary DI
B1830111450500
Brand
Canaveral®
Company
FLOSPINE LLC
Model
Canaveral®
Catalog number
01-1145-050
Device description
Polyaxial Screw Assembly, 4.5mm x 50mm
Published
2025-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System
OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

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
B1830111450500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length50Millimeter
Outer Diameter4.5Millimeter

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
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
07290115935578PER Trial 60PREMIA SPINE LTDNKB2026-07-22
07290115935691PER Trial 50PREMIA SPINE LTDNKB2026-07-22
00840466901035PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901035PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.KWP2026-07-21