Isobar

GUDID 03661380008887

Monoaxial hemispherical screw Ø 6.2 Lg 50 mm

SCIENT'X

Bone-screw internal spinal fixation system, sterile

Primary Device ID	03661380008887
NIH Device Record Key	4c9d5a11-1b13-4662-b8ce-d89c89c2c2b4
Commercial Distribution Discontinuation	2023-12-31
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Isobar
Version Model Number	12VDHL62-50
Company DUNS	502816283
Company Name	SCIENT'X
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter
Length	50 Millimeter
Outer Diameter	6.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661380008887 [Primary]

FDA Product Code

MNI	ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

[03661380008887]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2024-06-25
Device Publish Date	2015-09-10