Battalion Universal Spinal Spacer System

GUDID 00844856037809

BATTALION PC SPACER, PEEK-Ti, 10MM WIDE, 5 DEG, 25X13MM

ALPHATEC SPINE, INC.

Metal-polymer composite spinal interbody fusion cage
Primary Device ID00844856037809
NIH Device Record Key227e65a8-7f9c-4dff-a4bd-35b5cbd91ee7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBattalion Universal Spinal Spacer System
Version Model Number27013-020
Company DUNS602465783
Company NameALPHATEC SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)494-6840
Emailmfunk@alphatecspine.com

Device Dimensions

Angle5 degree
Angle5 degree
Angle5 degree
Angle5 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100844856037809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-24
Device Publish Date2015-08-31

On-Brand Devices [Battalion Universal Spinal Spacer System]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.