Battalion

GUDID 00190376240763

A-Arm Quick Connect, Right Angle, Blue

ALPHATEC SPINE, INC.

Operating table orthopaedic extension Operating table orthopaedic extension Operating table orthopaedic extension Operating table orthopaedic extension
Primary Device ID00190376240763
NIH Device Record Key27649b4c-cc1e-4e69-a4d7-cf36945c9a17
Commercial Distribution StatusIn Commercial Distribution
Brand NameBattalion
Version Model Number200-100
Company DUNS602465783
Company NameALPHATEC SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190376240763 [Primary]
GS100190376240763 [Primary]
GS100190376240763 [Primary]
GS100190376240763 [Primary]

FDA Product Code

CCXSUPPORT, PATIENT POSITION
CCXSUPPORT, PATIENT POSITION
CCXSUPPORT, PATIENT POSITION
CCXSUPPORT, PATIENT POSITION

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190376240763]

Moist Heat or Steam Sterilization


[00190376240763]

Moist Heat or Steam Sterilization


[00190376240763]

Moist Heat or Steam Sterilization


[00190376240763]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [Battalion]

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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.