FDA.reportPublic FDA data

Golden Isles Pedicle Screw System

Primary DI
G079C5040000010
Brand
Golden Isles Pedicle Screw System
Company
Intelivation, LLC
Model
C50-4000-001
Device description
French Rod Bender
Published
2022-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXPInstrument, Bending Or Contouring
HXWBender
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXPInstrument, Bending Or ContouringOrthopedic1
HXWBenderOrthopedic1
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G079C5040000010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(912) 434-2780contact@intelivationtech.com

Regulatory Flags#

DUNS number
037368183
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G079100120705S1Advantage C Cervical Interbody Fusion Device1001.20705S2026-07-24
G079100140705S1Advantage C Cervical Interbody Fusion Device1001.40705S2026-07-24
G079IVA22025000Golden Isles Pedicle Screw SystemIVA-2202-5002026-07-10
G079IVA22026000Golden Isles Pedicle Screw SystemIVA-2202-6002026-07-10
G079PDG2000Advantage-C Ti3D, Cervical InterbodyPDG-2002026-07-10
G079INL1390700Inlet Bone Fixation SystemINL-139-0702024-01-31
G079C2520000650Golden Isles Pedicle Screw SystemC25-2000-0652022-09-23
G079100140712S1Advantage C Cervical Interbody Fusion Device 1001.40712S2022-04-15
G079100150706S1Advantage C Cervical Interbody Fusion Device 1001.50706S2022-04-15
G079C5011000010Golden Isles Pedicle Screw SystemC50-1100-0012026-04-22
G079C5011000020Golden Isles Pedicle Screw SystemC50-1100-0022026-04-22
G079C5011000030Golden Isles Pedicle Screw SystemC50-1100-0032026-04-22
G079C5020000950Golden Isles Pedicle Screw SystemC50-2000-0952026-04-22
G079C5020001000Golden Isles Pedicle Screw SystemC50-2000-1002026-04-22
G079C5020001050Golden Isles Pedicle Screw SystemC50-2000-1052026-04-22
G079C5070000120Golden Isles Pedicle Screw SystemC50-7000-0122026-04-22
G079OSD000Golden Isles Pedicle Screw SystemOSD-002026-04-22
G079PAN0010Golden Isles Pedicle Screw SystemPAN-0012026-04-22
G079ADL120P28150Advantage -LUMBAR InterbodyADL-120P-28152026-04-20
G079ADL120P28160Advantage -LUMBAR InterbodyADL-120P-28162026-04-20

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