Battalion

GUDID 00840967106809

Battalion PC Spacer, PEEK-Ti, 10 mm wide, 5°, 35 mm X 10 mm, Sterile

ALPHATEC SPINE, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00840967106809
• NIH Device Record Key: 3c988642-95e1-4d8f-9aee-520c8cf4187c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Battalion
• Version Model Number: 27013-101-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: true
• 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

Device Dimensions

• Length: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840967106809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143740

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-01
• Device Publish Date: 2020-06-23

On-Brand Devices [Battalion]

• 00844856026247: Battalion PC Trial, SS, 10 mm wide, 5°, 35 mm X 15 mm
• 00844856026230: Battalion PC Trial, SS, 10 mm wide, 5°, 35 mm X 14 mm
• 00844856026216: Battalion PC Trial, SS, 10 mm wide, 5°, 35 mm X 13 mm
• 00844856026209: Battalion PC Trial, SS, 10 mm wide, 5°, 35 mm X 12 mm
• 00844856026193: Battalion PC Trial, SS, 10 mm wide, 5°, 35 mm X 11 mm
• 00844856026186: Battalion PC Trial, SS, 10 mm wide, 5°, 35 mm X 10 mm
• 00844856026179: Battalion PC Trial, SS, 10 mm wide, 5°, 35 mm X 9 mm
• 00844856026162: Battalion PC Trial, SS, 10 mm wide, 5°, 35 mm X 8 mm
• 00844856026070: Battalion PC Trial, SS, 10 mm wide, 5°, 35 mm X 7 mm
• 00844856018945: Battalion PC Trial, SS, 10 mm wide, 5°, 25 mm X 15 mm
• 00844856018938: Battalion PC Trial, SS, 10 mm wide, 5°, 25 mm X 14 mm
• 00844856018921: Battalion PC Trial, SS, 10 mm wide, 5°, 25 mm X 13 mm
• 00844856018914: Battalion PC Trial, SS, 10 mm wide, 5°, 25 mm X 12 mm
• 00844856018907: Battalion PC Trial, SS, 10 mm wide, 5°, 25 mm X 11 mm
• 00844856018891: Battalion PC Trial, SS, 10 mm wide, 5°, 25 mm X 10 mm
• 00844856018884: Battalion PC Trial, SS, 10 mm wide, 5°, 25 mm X 9 mm
• 00844856018877: Battalion PC Trial, SS, 10 mm wide, 5°, 25 mm X 8 mm
• 00844856018860: Battalion PC Trial, SS, 10 mm wide, 5°, 25 mm X 7 mm
• 00844856014183: Battalion PS Trial, SS, 9 mm wide, 5°, 35 mm X 15 mm
• 00844856014176: Battalion PS Trial, SS, 9 mm wide, 5°, 35 mm X 14 mm
• 00844856014169: Battalion PS Trial, SS, 9 mm wide, 5°, 35 mm X 13 mm
• 00844856014152: Battalion PS Trial, SS, 9 mm wide, 5°, 35 mm X 12 mm
• 00844856014145: Battalion PS Trial, SS, 9 mm wide, 5°, 35 mm X 11 mm
• 00844856013315: Battalion PS Trial, SS, 9 mm wide, 5°, 35 mm X 10 mm
• 00844856013308: Battalion PS Trial, SS, 9 mm wide, 5°, 35 mm X 9 mm
• 00844856013292: Battalion PS Trial, SS, 9 mm wide, 5°, 35 mm X 8 mm
• 00844856012141: Battalion PS Trial, SS, 9 mm wide, 5°, 35 mm X 7 mm
• 00844856008397: Battalion PS Trial, SS, 9 mm wide, 5°, 30 mm X 15 mm
• 00844856008380: Battalion PS Trial, SS, 9 mm wide, 5°, 30 mm X 14 mm
• 00844856008373: Battalion PS Trial, SS, 9 mm wide, 5°, 30 mm X 13 mm
• 00844856008366: Battalion PS Trial, SS, 9 mm wide, 5°, 30 mm X 12 mm
• 00844856008359: Battalion PS Trial, SS, 9 mm wide, 5°, 30 mm X 11 mm
• 00844856008342: Battalion PS Trial, SS, 9 mm wide, 5°, 30 mm X 10 mm
• 00844856008335: Battalion PS Trial, SS, 9 mm wide, 5°, 30 mm X 9 mm
• 00844856008328: Battalion PS Trial, SS, 9 mm wide, 5°, 30 mm X 8 mm
• 00844856008311: Battalion PS Trial, SS, 9 mm wide, 5°, 30 mm X 7 mm
• 00844856008113: Battalion PS Trial, SS, 9 mm wide, 5°, 25 mm X 15 mm
• 00844856008106: Battalion PS Trial, SS, 9 mm wide, 5°, 25 mm X 14 mm
• 00844856008090: Battalion PS Trial, SS, 9 mm wide, 5°, 25 mm X 13 mm
• 00844856008083: Battalion PS Trial, SS, 9 mm wide, 5°, 25 mm X 12 mm
• 00844856008076: Battalion PS Trial, SS, 9 mm wide, 5°, 25 mm X 11 mm
• 00844856008069: Battalion PS Trial, SS, 9 mm wide, 5°, 25 mm X 10 mm
• 00844856008052: Battalion PS Trial, SS, 9 mm wide, 5°, 25 mm X 9 mm
• 00844856008045: Battalion PS Trial, SS, 9 mm wide, 5°, 25 mm X 8 mm
• 00844856008038: Battalion PS Trial, SS, 9 mm wide, 5°, 25 mm X 7 mm
• 00844856006232: Battalion Inserter, Curved, Offset
• 00844856006171: Battalion Inserter, Curved, Axial
• 00844856005815: Battalion Inserter, Straight, Offset
• 00844856005693: Battalion Inserter, Straight, Axial
• 00840967189109: Battalion, LLIF Trial, 0°, 26 mm Wide, 17 mm X 90 mm