Battalion Lateral Spinal Spacer System

GUDID 00190376043043

Battalion Lateral Spacer, PEEK, 15°, 22 mm Wide, 16 x 60 mm

ALPHATEC SPINE, INC.

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 00190376043043
• NIH Device Record Key: 64febd03-b81b-4584-abc3-5aab0edcc18c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Battalion Lateral Spinal Spacer System
• Version Model Number: 27024-1345-S
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• 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: true
• 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

Device Dimensions

• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Angle: 15 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Length: 60 Millimeter
• Angle: 15 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Length: 60 Millimeter
• Angle: 15 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Length: 60 Millimeter
• Angle: 15 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Length: 60 Millimeter
• Angle: 15 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Length: 60 Millimeter
• Angle: 15 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Length: 60 Millimeter
• Angle: 15 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Length: 60 Millimeter
• Angle: 15 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Length: 60 Millimeter
• Angle: 15 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Length: 60 Millimeter
• Angle: 15 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Length: 60 Millimeter
• Angle: 15 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Length: 60 Millimeter
• Angle: 15 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Length: 60 Millimeter
• Angle: 15 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Length: 60 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376043043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160958

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-07-20

On-Brand Devices [Battalion Lateral Spinal Spacer System]

• 00190376043845: Battalion Lateral Spacer, PEEK, 0°, 18 mm Wide, 16 x 45 mm
• 00190376043838: Battalion Lateral Spacer, PEEK, 0°, 18 mm Wide, 14 x 45 mm
• 00190376043821: Battalion, LLIF Spacer, PEEK, 0 Deg, 18mm Wide, 12 x 45mm, Sterile
• 00190376043814: Battalion, LLIF Spacer, PEEK, 0 Deg, 18mm Wide, 10 x 45mm, Sterile
• 00190376043807: Battalion, LLIF Spacer, PEEK, 0 Deg, 18mm Wide, 8 x 45mm, Sterile
• 00190376043043: Battalion Lateral Spacer, PEEK, 15°, 22 mm Wide, 16 x 60 mm
• 00190376043036: Battalion Lateral Spacer, PEEK, 15°, 22 mm Wide, 14 x 60 mm
• 00190376043029: Battalion, LLIF Spacer, PEEK, 15 Deg, 22mm Wide, 12 x 60mm, Sterile
• 00190376043012: Battalion, LLIF Spacer, PEEK, 10 Deg, 22mm Wide, 10 x 60mm, Sterile
• 00190376043005: Battalion, LLIF Spacer, PEEK, 6 Deg, 22mm Wide, 8 x 60mm, Sterile
• 00190376042978: Battalion Lateral Spacer, PEEK, 15°, 22 mm Wide, 16 x 55 mm
• 00190376042961: Battalion Lateral Spacer, PEEK, 15°, 22 mm Wide, 14 x 55 mm
• 00190376042954: Battalion, LLIF Spacer, PEEK, 15 Deg, 22mm Wide, 12 x 55mm, Sterile
• 00190376042947: Battalion, LLIF Spacer, PEEK, 10 Deg, 22mm Wide, 10 x 55mm, Sterile
• 00190376042930: Battalion, LLIF Spacer, PEEK, 6 Deg, 22mm Wide, 8 x 55mm, Sterile
• 00190376042909: Battalion, LLIF Spacer, PEEK, 15 Deg, 22mm Wide, 16 x 50mm, Sterile
• 00190376042893: Battalion, LLIF Spacer, PEEK, 15 Deg, 22mm Wide, 14 x 50mm, Sterile
• 00190376042886: Battalion, LLIF Spacer, PEEK, 15 Deg, 22mm Wide, 12 x 50mm, Sterile
• 00190376042879: Battalion, LLIF Spacer, PEEK, 10 Deg, 22mm Wide, 10 x 50mm, Sterile
• 00190376042862: Battalion, LLIF Spacer, PEEK, 6 Deg, 22mm Wide, 8 x 50mm, Sterile
• 00190376042831: Battalion Lateral Spacer, PEEK, 15°, 22 mm Wide, 16 x 45 mm
• 00190376042824: Battalion Lateral Spacer, PEEK, 15°, 22 mm Wide, 14 x 45 mm
• 00190376042817: Battalion, LLIF Spacer, PEEK, 15 Deg, 22mm Wide, 12 x 45mm, Sterile
• 00190376042800: Battalion, LLIF Spacer, PEEK, 10 Deg, 22mm Wide, 10 x 45mm, Sterile
• 00190376042794: Battalion, LLIF Spacer, PEEK, 6 Deg, 22mm Wide, 8 x 45mm, Sterile
• 00190376041001: Battalion Lateral Spacer, PEEK, 0°, 22 mm Wide, 16 x 60 mm
• 00190376040998: Battalion Lateral Spacer, PEEK, 0°, 22 mm Wide, 14 x 60 mm
• 00190376040981: Battalion, LLIF Spacer, PEEK, 0 Deg, 22mm Wide, 12 x 60mm, Sterile
• 00190376040974: Battalion, LLIF Spacer, PEEK, 0 Deg, 22mm Wide, 10 x 60mm, Sterile
• 00190376040967: Battalion, LLIF Spacer, PEEK, 0 Deg, 22mm Wide, 8 x 60mm, Sterile
• 00190376040929: Battalion Lateral Spacer, PEEK, 0°, 22 mm Wide, 16 x 55 mm
• 00190376040912: Battalion Lateral Spacer, PEEK, 0°, 22 mm Wide, 14 x 55 mm
• 00190376040905: Battalion, LLIF Spacer, PEEK, 0 Deg, 22mm Wide, 12 x 55mm, Sterile
• 00190376040899: Battalion, LLIF Spacer, PEEK, 0 Deg, 22mm Wide, 10 x 55mm, Sterile
• 00190376040882: Battalion, LLIF Spacer, PEEK, 0 Deg, 22mm Wide, 8 x 55mm, Sterile
• 00190376040844: Battalion Lateral Spacer, PEEK, 0°, 22 mm Wide, 16 x 50 mm
• 00190376040837: Battalion, LLIF Spacer, PEEK, 0 Deg, 22mm Wide, 14 x 50mm, Sterile
• 00190376040820: Battalion, LLIF Spacer, PEEK, 0 Deg, 22mm Wide, 12 x 50mm, Sterile
• 00190376040813: Battalion, LLIF Spacer, PEEK, 0 Deg, 22mm Wide, 10 x 50mm, Sterile
• 00190376040806: Battalion, LLIF Spacer, PEEK, 0 Deg, 22mm Wide, 8 x 50mm, Sterile
• 00190376040769: Battalion Lateral Spacer, PEEK, 0°, 22 mm Wide, 16 x 45 mm
• 00190376040752: Battalion Lateral Spacer, PEEK, 0°, 22 mm Wide, 14 x 45 mm
• 00190376040745: Battalion, LLIF Spacer, PEEK, 0 Deg, 22mm Wide, 12 x 45mm, Sterile
• 00190376040738: Battalion, LLIF Spacer, PEEK, 0 Deg, 22mm Wide, 10 x 45mm, Sterile
• 00190376040721: Battalion, LLIF Spacer, PEEK, 0 Deg, 22mm Wide, 8 x 45mm, Sterile
• 00190376040455: Battalion Lateral Spacer, PEEK, 15°, 18 mm Wide, 16 x 60 mm
• 00190376040448: Battalion Lateral Spacer, PEEK, 15°, 18 mm Wide, 14 x 60 mm
• 00190376040431: Battalion, LLIF Spacer, PEEK, 15 Deg, 18mm Wide, 12 x 60mm, Sterile
• 00190376040424: Battalion, LLIF Spacer, PEEK, 10 Deg, 18mm Wide, 10 x 60mm, Sterile
• 00190376040417: Battalion, LLIF Spacer, PEEK, 6 Deg, 18mm Wide, 8 x 60mm, Sterile