FDA.reportPublic FDA data

Golden Isles Pedicle Screw System

Primary DI
G079C2522020800
Brand
Golden Isles Pedicle Screw System
Company
Intelivation, LLC
Model
C25-2202-080
Device description
Straight Cobalt Chrome Rod, Extended Hex
Published
2022-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G079C2522020800PrimaryHIBCC0

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
Length80Millimeter

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G079HMR2020Hammerdesis™ Interphalangeal Fusion SystemHMR-2022026-03-05
G079HMR3020Hammerdesis™ Interphalangeal Fusion SystemHMR-3022026-03-05
G079HMR4020Hammerdesis™ Interphalangeal Fusion SystemHMR-4022026-03-05
G079C2520003900Golden Isles Pedicle Screw SystemC25-2000-3902026-03-04
G079C2520004000Golden Isles Pedicle Screw SystemC25-2000-4002026-03-04
G079C2520004100Golden Isles Pedicle Screw SystemC25-2000-4102026-03-04
G079C2520004200Golden Isles Pedicle Screw SystemC25-2000-4202026-03-04
G079C2520004300Golden Isles Pedicle Screw SystemC25-2000-4302026-03-04
G079C2520004400Golden Isles Pedicle Screw SystemC25-2000-4402026-03-04
G079C2520004500Golden Isles Pedicle Screw SystemC25-2000-4502026-03-04
G079C2520004600Golden Isles Pedicle Screw SystemC25-2000-4602026-03-04
G079C2520004700Golden Isles Pedicle Screw SystemC25-2000-4702026-03-04
G079C2520004800Golden Isles Pedicle Screw SystemC25-2000-4802026-03-04
G079C2520004900Golden Isles Pedicle Screw SystemC25-2000-4902026-03-04
G079C2520005000Golden Isles Pedicle Screw SystemC25-2000-5002026-03-04
G079C2520002600Golden Isles Pedicle Screw SystemC25-2000-2602026-03-03
G079C2520002700Golden Isles Pedicle Screw SystemC25-2000-2702026-03-03
G079C2520002800Golden Isles Pedicle Screw SystemC25-2000-2802026-03-03
G079C2520002900Golden Isles Pedicle Screw SystemC25-2000-2902026-03-03
G079C2520003000Golden Isles Pedicle Screw SystemC25-2000-3002026-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008401853825664CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825734CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825804CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825974CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
07290014381254ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290014381261ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290115935615Counter Torque STPREMIA SPINE LTDNKB2026-05-25
06941312465757Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465764Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465771Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465788Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465795Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465801Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465818Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465825Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465832Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465849Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465856Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465887Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465894Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465900Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465559Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465566Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465573Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465580Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465597Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465603Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465610Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465627Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465634Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22