FDA.reportPublic FDA data

Golden Isles Pedicle Screw System

Primary DI
G079C5020010040
Brand
Golden Isles Pedicle Screw System
Company
Intelivation, LLC
Model
C50-2001-004
Device description
Cannulated Probe, Straight
Published
2022-10-26
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
HXBProbe
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G079C5020010040PrimaryHIBCC0

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
(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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9213821020Surgical DirectSurgical Direct, Inc.HXB2026-08-07
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
B382SD483800190Surgical DirectSurgical Direct, Inc.HXB2026-08-03
B382SD4838920Surgical DirectSurgical Direct, Inc.HXB2026-08-03
M719GL3110TiLockGenesys Orthopedics Systems LLCNKB2026-08-03
M719GLC403S0TiLockGenesys Orthopedics Systems LLCNKB2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCNKB2026-08-03
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-08-02
00840606191593Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840606191869Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840606191876Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-30
00840493425382RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28