FDA.reportPublic FDA data

Golden Isles Pedicle Screw System

Primary DI
G079C5070000010
Brand
Golden Isles Pedicle Screw System
Company
Intelivation, LLC
Model
C50-7000-001
Device description
Set-Screw Inserter, Double-Sided
Published
2022-09-23
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G079C5070000010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
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

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