MIS Golden Isles Pedicle Screw System

GUDID G079C25200A1300

Ø5.5mm MIS Curved Rod, 130mm

Intelivation, LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device IDG079C25200A1300
NIH Device Record Keye6b748e7-20a5-4f91-93aa-6327c50a994c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMIS Golden Isles Pedicle Screw System
Version Model NumberC25-200A-130
Company DUNS037368183
Company NameIntelivation, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com
Phone9124342780
Emailcontact@intelivationtech.com

Device Dimensions

Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter
Length130 Millimeter
Outer Diameter5.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG079C25200A1300 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

[G079C25200A1300]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-05
Device Publish Date2023-04-27

On-Brand Devices [MIS Golden Isles Pedicle Screw System ]

G079C511000A020MIS Reduction Headbody
G079C510000A030MIS Extended Tab
G079C25200A300Ø5.5mm MIS Curved Rod, 30mm
G079C25200A2500Ø5.5mm MIS Curved Rod, 250mm
G079C25200A2400Ø5.5mm MIS Curved Rod, 240mm
G079C25200A2300Ø5.5mm MIS Curved Rod, 230mm
G079C25200A2200Ø5.5mm MIS Curved Rod, 220mm
G079C25200A2100Ø5.5mm MIS Curved Rod, 210mm
G079C25200A2000Ø5.5mm MIS Curved Rod, 200mm
G079C25200A1900Ø5.5mm MIS Curved Rod, 190mm
G079C25200A1800Ø5.5mm MIS Curved Rod, 180mm
G079C25200A1700Ø5.5mm MIS Curved Rod, 170mm
G079C25200A1600Ø5.5mm MIS Curved Rod, 160mm
G079C25200A1500Ø5.5mm MIS Curved Rod, 150mm
G079C25200A1400Ø5.5mm MIS Curved Rod, 140mm
G079C25200A1300Ø5.5mm MIS Curved Rod, 130mm
G079C25200A1200Ø5.5mm MIS Curved Rod, 120mm
G079C25200A1100Ø5.5mm MIS Curved Rod, 110mm
G079C25200A1000Ø5.5mm MIS Curved Rod, 100mm
G079C25200A0950Ø5.5mm MIS Curved Rod, 95mm
G079C25200A0900Ø5.5mm MIS Curved Rod, 90mm
G079C25200A0850Ø5.5mm MIS Curved Rod, 85mm
G079C25200A0800Ø5.5mm MIS Curved Rod, 80mm
G079C25200A0750Ø5.5mm MIS Curved Rod, 75mm
G079C25200A0700Ø5.5mm MIS Curved Rod, 70mm
G079C25200A0650Ø5.5mm MIS Curved Rod, 65mm
G079C25200A0600Ø5.5mm MIS Curved Rod, 60mm
G079C25200A0550Ø5.5mm MIS Curved Rod, 55mm
G079C25200A0500Ø5.5mm MIS Curved Rod, 50mm
G079C25200A0450Ø5.5mm MIS Curved Rod, 45mm
G079C25200A0400Ø5.5mm MIS Curved Rod, 40mm
G079C25200A0350Ø5.5mm MIS Curved Rod, 35mm
G070C511000A010MIS Standard Headbody
G079C50800000220K-wire 45mm screw Standard Driver
G079CC5080000010Modified MIS Driver
G079CC5030000090Modified Reduction Driver
G079C5080000210Impaction Cap
G079C5080000200Shorter Driver
G079C5080000160Set Screw Shaft C/D
G079C5080000110MIS Rod Holder
G079C5080000090Screw Depth Measuring Instrument
G079C5080000080MIS Tab Breaker
G079C5080000070MIS Counter Torque Proximal
G079C5080000060Rod Indicator
G079C5080000050MIS Counter Torque Distal
G079C5080000040MIS Final Tightener shaft
G079C5080000030MIS Provisional Locking Cap Driver
G079C5080000020MIS Tab Inserter
G079C5080000010MIS Driver
G079C500000A02C0GI MIS Screw Caddy
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