FDA.reportPublic FDA data

Canaveral®

Primary DI
B183180000020
Brand
Canaveral®
Company
FLOSPINE LLC
Model
Canaveral®
Catalog number
01-7000-001
Device description
Lid, Canaveral Pedicle Screw System
Published
2016-06-30
Public version status
Update
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
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
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
B183180000020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic feelerA hand-held manual surgical instrument designed to identify the position and/or shape of bone structures and/or cavities created within these structures, e.g., the angle of a drilled hole, during surgery. It is typically designed as a long, thin, shaft with a handle or handle connector at the proximal end and typically a round ball-tip at the distal end. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon to recognize structures and cavities through a tactile feedback. This is a reusable device.

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
Manufacturing date on label
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
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
M719GL3110TiLockGenesys Orthopedics Systems LLCMNH2026-08-03
M719GL3110TiLockGenesys Orthopedics Systems LLCMNI2026-08-03
M719GL3110TiLockGenesys Orthopedics Systems LLCNKB2026-08-03
M719GLC403S0TiLockGenesys Orthopedics Systems LLCNKB2026-08-03
M719GLC403S0TiLockGenesys Orthopedics Systems LLCMNI2026-08-03
M719GLC403S0TiLockGenesys Orthopedics Systems LLCMNH2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCNKB2026-08-03
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-08-02
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-08-02
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2026-08-02
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-08-02
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-08-02