Battalion Universal Spinal Spacer System

GUDID 00844856035447

BATTALION PS SPACER, PEEK-Ti, 11MM WIDE, 5 DEG, 20X13MM

ALPHATEC SPINE, INC.

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 00844856035447
• NIH Device Record Key: 6ed7c327-e015-4204-8015-6417f462f2ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Battalion Universal Spinal Spacer System
• Version Model Number: 27012-062
• 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)494-6840
• Email: mfunk@alphatecspine.com

Device Dimensions

• Width: 11 Millimeter
• Width: 11 Millimeter
• Width: 11 Millimeter
• Width: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856035447 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-08-31

On-Brand Devices [Battalion Universal Spinal Spacer System]

• 00844856091320: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 30X20MM
• 00844856091313: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 30X19MM
• 00844856091306: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 30X18MM
• 00844856091290: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 30X17MM
• 00844856091283: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 30X16MM
• 00844856091276: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 30X15MM
• 00844856091269: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 30X14MM
• 00844856091252: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 30X13MM
• 00844856091245: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 30X12MM
• 00844856091238: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 30X11MM
• 00844856091221: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 30X10MM
• 00844856091214: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 30X9MM
• 00844856091207: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 30X8MM
• 00844856091191: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 30X7MM
• 00844856091047: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 25X20MM
• 00844856091030: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 25X19MM
• 00844856091023: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 25X18MM
• 00844856091016: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 25X17MM
• 00844856091009: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 25X16MM
• 00844856090996: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 25X15MM
• 00844856090989: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 25X14MM
• 00844856090972: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 25X13MM
• 00844856090965: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 25X12MM
• 00844856090958: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 25X11MM
• 00844856090941: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 25X10MM
• 00844856090934: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 25X9MM
• 00844856090927: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 25X8MM
• 00844856090910: BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 10 DEG, 25X7MM
• 00844856090620: BATTALION PS SPACER, PEEK-Ti, 11MM WIDE, 10 DEG, 35X20MM
• 00844856090613: BATTALION PS SPACER, PEEK-Ti, 11MM WIDE, 10 DEG, 35X19MM
• 00844856090606: BATTALION PS SPACER, PEEK-Ti, 11MM WIDE, 10 DEG, 35X18MM
• 00844856090590: BATTALION PS SPACER, PEEK-Ti, 11MM WIDE, 10 DEG, 35X17MM
• 00844856090583: BATTALION PS SPACER, PEEK-Ti, 11MM WIDE, 10 DEG, 35X16MM
• 00844856090576: BATTALION PS SPACER, PEEK-Ti, 11MM WIDE, 10 DEG, 35X15MM
• 00844856090569: BATTALION PS SPACER, PEEK-Ti, 11MM WIDE, 10 DEG, 35X14MM
• 00844856090552: BATTALION PS SPACER, PEEK-Ti, 11MM WIDE, 10 DEG, 35X13MM
• 00844856090545: BATTALION PS SPACER, PEEK-Ti, 11MM WIDE, 10 DEG, 35X12MM
• 00844856090538: BATTALION PS SPACER, PEEK-Ti, 11MM WIDE, 10 DEG, 35X11MM
• 00844856090521: BATTALION PS SPACER, PEEK-Ti, 11MM WIDE, 10 DEG, 35X10MM
• 00844856090514: BATTALION PS SPACER, PEEK-Ti, 11MM WIDE, 10 DEG, 35X9MM
• 00844856090507: BATTALION PS SPACER, PEEK-Ti, 11MM WIDE, 10 DEG, 35X8MM
• 00844856090491: BATTALION PS SPACER, PEEK-Ti, 11MM WIDE, 10 DEG, 35X7MM
• 00844856090200: BATTALION PS SPACER, PEEK-Ti, 9MM WIDE, 10 DEG, 25X20MM
• 00844856090194: BATTALION PS SPACER, PEEK-Ti, 9MM WIDE, 10 DEG, 25X19MM
• 00844856090187: BATTALION PS SPACER, PEEK-Ti, 9MM WIDE, 10 DEG, 25X18MM
• 00844856090170: BATTALION PS SPACER, PEEK-Ti, 9MM WIDE, 10 DEG, 25X17MM
• 00844856090163: BATTALION PS SPACER, PEEK-Ti, 9MM WIDE, 10 DEG, 25X16MM
• 00844856090156: BATTALION PS SPACER, PEEK-Ti, 9MM WIDE, 10 DEG, 25X15MM
• 00844856090149: BATTALION PS SPACER, PEEK-Ti, 9MM WIDE, 10 DEG, 25X14MM
• 00844856090132: BATTALION PS SPACER, PEEK-Ti, 9MM WIDE, 10 DEG, 25X13MM