FDA.reportPublic FDA data

MIS Golden Isles Pedicle Screw System

Primary DI
G079C5080000260
Brand
MIS Golden Isles Pedicle Screw System
Company
Intelivation, LLC
Model
C50-8000-026
Device description
GI MIS Head Turner
Published
2026-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G079C5080000260PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
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
G079ADL120P32080Advantage -LUMBAR InterbodyADL-120P-32082026-04-20
G079ADL120P32090Advantage -LUMBAR InterbodyADL-120P-32092026-04-20
G079ADL120P32100Advantage -LUMBAR InterbodyADL-120P-32102026-04-20
G079ADL120P32110Advantage -LUMBAR InterbodyADL-120P-32112026-04-20
G079ADL120P32120Advantage -LUMBAR InterbodyADL-120P-32122026-04-20

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