FDA.reportPublic FDA data

MIS Golden Isles Pedicle Screw System

Primary DI
G079C25200A0700
Brand
MIS Golden Isles Pedicle Screw System
Company
Intelivation, LLC
Model
C25-200A-070
Device description
Ø5.5mm MIS Curved Rod, 70mm
Published
2023-04-27
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
KNBInstrument, Destructive, Fetal, Obstetric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNBInstrument, Destructive, Fetal, ObstetricObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G079C25200A0700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length70Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9124342780contact@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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843672101725INGENIXINGENIUMSPINE, LLCKNB2025-02-24
00843672101831INGENIXINGENIUMSPINE, LLCKNB2025-02-24
00840314118998Nex-D2NEXT ORTHOSURGICAL, INC.KNB2024-08-28
G079C25200A0650MIS Golden Isles Pedicle Screw System Intelivation, LLCKNB2023-04-27
00815500024636DymaxeonBACK 2 BASIC DIRECT, LLCKNB2019-02-01
08806162106879AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KNB2015-10-13
08806162107418AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KNB2015-10-13