Sigma

GUDID 00190376270142

COBB, SIGMA

ALPHATEC SPINE, INC.

Bone lever/elevator

• Primary Device ID: 00190376270142
• NIH Device Record Key: 37b5becc-71fe-4a79-9cbd-83e2fb458c71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sigma
• Version Model Number: 269-600
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376270142 [Primary]

FDA Product Code

• HTE: ELEVATOR

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00190376270142]

Moist Heat or Steam Sterilization

[00190376270142]

Moist Heat or Steam Sterilization

[00190376270142]

Moist Heat or Steam Sterilization

[00190376270142]

Moist Heat or Steam Sterilization

[00190376270142]

Moist Heat or Steam Sterilization

[00190376270142]

Moist Heat or Steam Sterilization

[00190376270142]

Moist Heat or Steam Sterilization

[00190376270142]

Moist Heat or Steam Sterilization

[00190376270142]

Moist Heat or Steam Sterilization

[00190376270142]

Moist Heat or Steam Sterilization

[00190376270142]

Moist Heat or Steam Sterilization

[00190376270142]

Moist Heat or Steam Sterilization

[00190376270142]

Moist Heat or Steam Sterilization

[00190376270142]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-09
• Device Publish Date: 2020-10-30

On-Brand Devices [Sigma]

• 00190376276311: Sigma TLIF Access System
• 00190376276267: Sigma TLIF A-Arm
• 00190376279169: LATERAL ARM, RIGHT
• 00190376279152: LATERAL ARM, LEFT
• 00190376270784: SMALL MEDIAL BLADE, SIGMA
• 00190376270777: 120mm C-C BLADE, SIGMA
• 00190376270760: 110mm C-C BLADE, SIGMA
• 00190376270753: 100mm C-C BLADE, SIGMA
• 00190376270746: 90mm C-C BLADE, SIGMA
• 00190376270739: 80mm C-C BLADE, SIGMA
• 00190376270722: 70mm C-C BLADE, SIGMA
• 00190376270715: 60mm C-C BLADE, SIGMA
• 00190376270708: 50mm C-C BLADE, SIGMA
• 00190376270692: XL MEDIAL BLADE, SIGMA
• 00190376270685: LARGE MEDIAL BLADE, SIGMA
• 00190376270678: MEDIUM MEDIAL BLADE, SIGMA
• 00190376270166: SIGMA RETRACTOR
• 00190376270142: COBB, SIGMA
• 00190376270135: SPLAY KNOB DRIVER, SIGMA
• 00190376270128: ACCESS HEX DRIVER, T-HANDLE, SIGMA
• 00190376270111: T25 BALL-HEX DRIVER, IN-LINE, SIGMA
• 00190376270104: MEDIAL BLADE INSERTER, SIGMA
• 00190376316604: 120mm C-C Blade, Sigma TLIF
• 00190376316598: 110mm C-C Blade, Sigma TLIF
• 00190376316581: 100mm C-C Blade, Sigma TLIF
• 00190376316574: 90mm C-C Blade, Sigma TLIF
• 00190376316567: 80mm C-C Blade, Sigma TLIF
• 00190376316550: 70mm C-C Blade, Sigma TLIF
• 00190376316543: 60mm C-C Blade, Sigma TLIF
• 00190376316536: 50mm C-C Blade, Sigma TLIF
• 00190376330716: RIGHT EXPOSURE GUARD, LONG, SIGMA TLIF ACCESS
• 00190376330709: LEFT EXPOSURE GUARD, LONG, SIGMA TLIF ACCESS
• 00190376330693: RIGHT EXPOSURE GUARD, SHORT, SIGMA TLIF ACCESS
• 00190376330686: LEFT EXPOSURE GUARD, SHORT, SIGMA TLIF ACCESS
• 00190376330679: ILLUMINATION GUIDE, SIGMA TLIF ACCESS
• 00190376330662: BLADE WING, RIGHT, SIGMA TLIF
• 00190376330655: BLADE WING, LEFT, SIGMA TLIF
• 00190376397153: SIGMA LTP BLADE EXTENDER, WIDE, 30mm
• 00190376397146: SIGMA LTP BLADE EXTENDER, WIDE, 28mm
• 00190376397139: SIGMA LTP BLADE EXTENDER, WIDE, 26mm
• 00190376397122: SIGMA LTP BLADE EXTENDER, NARROW, 30mm
• 00190376397115: SIGMA LTP BLADE EXTENDER, NARROW, 28mm
• 00190376397108: SIGMA LTP BLADE EXTENDER, NARROW, 26mm
• 00190376397092: SIGMA LTP INTRADISCAL SHIM, WIDE
• 00190376397085: SIGMA LTP INTRADISCAL SHIM, NARROW
• 00190376395272: SIGMA LTP CROSS BAR
• 00190376394671: INLINE A-ARM EXTENSION
• 00190376394664: SIGMA LTP STEERING HANDLE
• 00190376394640: TERTIARY DILATOR, ELLIPTICAL
• 00190376394527: SIGMA LTP ALL RETRACTOR, 230mm