Core Lumbar Fixation System

GUDID 00844856021839

ROC NUT FULLY THREADED

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00844856021839
NIH Device Record Key9dd44042-cad6-48a5-b6f8-36099805b37a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCore Lumbar Fixation System
Version Model Number81009
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 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
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
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
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100844856021839 [Primary]
GS100844856021839 [Primary]
GS100844856021839 [Primary]
GS100844856021839 [Primary]
GS100844856021839 [Primary]
GS100844856021839 [Primary]
GS100844856021839 [Primary]
GS100844856021839 [Primary]
GS100844856021839 [Primary]
GS100844856021839 [Primary]
GS100844856021839 [Primary]
GS100844856021839 [Primary]
GS100844856021839 [Primary]
GS100844856021839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation
MNHOrthosis, spondylolisthesis spinal fixation
MNHOrthosis, spondylolisthesis spinal fixation
MNHOrthosis, spondylolisthesis spinal fixation
MNHOrthosis, spondylolisthesis spinal fixation
MNHOrthosis, spondylolisthesis spinal fixation
MNHOrthosis, spondylolisthesis spinal fixation
MNHOrthosis, spondylolisthesis spinal fixation
MNHOrthosis, spondylolisthesis spinal fixation
MNHOrthosis, spondylolisthesis spinal fixation
MNHOrthosis, spondylolisthesis spinal fixation
MNHOrthosis, spondylolisthesis spinal fixation
MNHOrthosis, spondylolisthesis spinal fixation
MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00844856021839]

Moist Heat or Steam Sterilization


[00844856021839]

Moist Heat or Steam Sterilization


[00844856021839]

Moist Heat or Steam Sterilization


[00844856021839]

Moist Heat or Steam Sterilization


[00844856021839]

Moist Heat or Steam Sterilization


[00844856021839]

Moist Heat or Steam Sterilization


[00844856021839]

Moist Heat or Steam Sterilization


[00844856021839]

Moist Heat or Steam Sterilization


[00844856021839]

Moist Heat or Steam Sterilization


[00844856021839]

Moist Heat or Steam Sterilization


[00844856021839]

Moist Heat or Steam Sterilization


[00844856021839]

Moist Heat or Steam Sterilization


[00844856021839]

Moist Heat or Steam Sterilization


[00844856021839]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

On-Brand Devices [Core Lumbar Fixation System]

00844856045439TI STANDARD HIGH-TOP PEDICLE BOLT - 7.5MM X 40MM
00844856045422TI ELEVATED PEDICLE BOLT - 7.5mm X 40mm
00844856031548ROC 2 SLOT PLATE
00844856021853LARGE ROC ROD CONNECTOR, TI
00844856021846SMALL ROC ROD CONNECTOR, TI
00844856021839ROC NUT FULLY THREADED
00844856021822ROC 3MM SPACER
00844856021808ROC SLOTTED OFFSET LINK
00844856021730ROC 4 SLOT PLATE 128mm
00844856021723ROC 4 SLOT PLATE 114mm
00844856021693ROC 3 SLOT PLATE 90mm
00844856021686ROC 3 SLOT PLATE 76mm
00844856021679ROC 3 SLOT PLATE 62mm
00844856021648ROC 2 SLOT PLATE
0084485602162427MM 1 SINGLE SLOT PRE-CONTOURED PLATE
00844856021617PRE-CONTOURED SINGLE SLOT 23MM PLATE , TI
00840967194875TI STANDARD HIGH-TOP PEDICLE BOLT - 8.5MMX 40MM
00840967194868TI STANDARD HIGH-TOP PEDICLE BOLT - 8.5MMX 35MM
00840967194813TI ELEVATED HIGH -TOP PEDICLE BOLT- 7.5MM X 40MM
00840967194769TI STANDARD HIGH-TOP PEDICLE BOLT - 7.5MM X 45MM
00840967194752TI STANDARD HIGH-TOP PEDICLE BOLT - 7.5MM X 35MM
00840967194530TI STANDARD HIGH-TOP PEDICLE BOLT, 6.5MM X 45MM
00840967194523TI STANDARD HIGH-TOP PEDICLE BOLT, 6.5MM X 40MM
00840967194516TI STANDARD HIGH-TOP PEDICLE BOLT, 6.5MM X 35MM
00840967194349TI ELEVATED PEDICLE BOLT - 8.5mm X 40mm
00840967194301TI STANDARD PEDICLE BOLT - 8.5mm X 80mm
00840967194295TI STANDARD PEDICLE BOLT - 8.5mm X 65mm
00840967194288TI STANDARD PEDICLE BOLT - 8.5mm X 50mm
00840967194271TI STANDARD PEDICLE BOLT - 8.5mm X 45mm
00840967194257TI STANDARD PEDICLE BOLT - 8.5mm X 35mm
00840967194219TI ELEVATED PEDICLE BOLT - 7.5mm X 45mm
00840967194202TI ELEVATED PEDICLE BOLT - 7.5mm X 35mm
00840967194141TI STANDARD PEDICLE BOLT - 7.5mm X 45mm
00840967194134TI STANDARD PEDICLE BOLT - 7.5mm X 40mm
00840967194127TI STANDARD PEDICLE BOLT - 7.5mm X 35mm
00840967193960TI ELEVATED PEDICLE BOLT - 6.5mm X 45mm
00840967193953TI ELEVATED PEDICLE BOLT - 6.5mm X 40mm
00840967193946TI ELEVATED PEDICLE BOLT - 6.5mm X 35mm
00840967193908TI STANDARD PEDICLE BOLT - 6.5mm X 45mm
00840967193892TI STANDARD PEDICLE BOLT - 6.5mm X 40mm
00840967193885TI STANDARD PEDICLE BOLT - 6.5mm X 35mm
00840967193786TI STANDARD PEDICLE BOLT - 5.5mm X 45mm
00840967193779TI STANDARD PEDICLE BOLT - 5.5mm X 40mm
00840967193687IN-SITU ROD COUPLER, TOP LOADING
008409671936566.35mm ADJUSTABLE BRIDGE, 37mm - 45mm
008409671936496.35mm ADJUSTABLE BRIDGE, 29mm - 39mm
008409671936326.35mm ADJUSTABLE BRIDGE, 24mm - 30mm

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