Isobar

GUDID 03661380009082

Monoaxial hemispherical screw Ø 8.0 Lg 50 mm

SCIENT'X

Bone-screw internal spinal fixation system, sterile
Primary Device ID03661380009082
NIH Device Record Keyb4403ca1-e1a0-4f6d-b768-ea37c670410a
Commercial Distribution Discontinuation2023-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIsobar
Version Model Number12VDHS80-50
Company DUNS502816283
Company NameSCIENT'X
Device Count1
DM Exempttrue
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

Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com
Phone+1(760)494-6840
Emailmfunk@alphatecspine.com

Device Dimensions

Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter
Outer Diameter8 Millimeter
Length50 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103661380009082 [Primary]

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


[03661380009082]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-06-25
Device Publish Date2015-09-10