Battalion Lateral Spinal Spacer System

GUDID 00190376043821

Battalion, LLIF Spacer, PEEK, 0 Deg, 18mm Wide, 12 x 45mm, Sterile

ALPHATEC SPINE, INC.

Metal-polymer composite spinal interbody fusion cage

Primary Device ID	00190376043821
NIH Device Record Key	cbfa0506-47ff-4cf5-aec9-a510cb0bf454
Commercial Distribution Status	In Commercial Distribution
Brand Name	Battalion Lateral Spinal Spacer System
Version Model Number	27024-0036-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

Height	12 Millimeter
Height	12 Millimeter
Height	12 Millimeter
Length	45 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Length	45 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Length	45 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Length	45 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Length	45 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Length	45 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Length	45 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Length	45 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Length	45 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Length	45 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Length	45 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Length	45 Millimeter
Width	18 Millimeter
Height	12 Millimeter
Length	45 Millimeter
Width	18 Millimeter
Height	12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376043821 [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