Illico Posterior Fixation System

GUDID 00844856043473

Pre-Contoured / C.P. TI Rod 5.5 mm X 170 mm

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system 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 ID00844856043473
NIH Device Record Keye29ffe1f-306f-4dc6-ba69-6f49d8c7a820
Commercial Distribution StatusIn Commercial Distribution
Brand NameIllico Posterior Fixation System
Version Model Number73600-170
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 Dimensions

Length170 Millimeter
Length170 Millimeter
Outer Diameter5.5 Millimeter
Length17 Centimeter
Outer Diameter5.5 Millimeter
Length17 Centimeter
Outer Diameter5.5 Millimeter
Length17 Centimeter
Outer Diameter5.5 Millimeter
Length17 Centimeter
Outer Diameter5.5 Millimeter
Length17 Centimeter
Outer Diameter5.5 Millimeter
Length17 Centimeter
Outer Diameter5.5 Millimeter
Length17 Centimeter
Outer Diameter5.5 Millimeter
Length17 Centimeter
Outer Diameter5.5 Millimeter
Length17 Centimeter
Outer Diameter5.5 Millimeter
Length17 Centimeter
Outer Diameter5.5 Millimeter
Length17 Centimeter
Outer Diameter5.5 Millimeter
Length17 Centimeter
Outer Diameter5.5 Millimeter
Length17 Centimeter
Outer Diameter5.5 Millimeter
Length17 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100844856043473 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation
NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00844856043473]

Moist Heat or Steam Sterilization


[00844856043473]

Moist Heat or Steam Sterilization


[00844856043473]

Moist Heat or Steam Sterilization


[00844856043473]

Moist Heat or Steam Sterilization


[00844856043473]

Moist Heat or Steam Sterilization


[00844856043473]

Moist Heat or Steam Sterilization


[00844856043473]

Moist Heat or Steam Sterilization


[00844856043473]

Moist Heat or Steam Sterilization


[00844856043473]

Moist Heat or Steam Sterilization


[00844856043473]

Moist Heat or Steam Sterilization


[00844856043473]

Moist Heat or Steam Sterilization


[00844856043473]

Moist Heat or Steam Sterilization


[00844856043473]

Moist Heat or Steam Sterilization


[00844856043473]

Moist Heat or Steam Sterilization


[00844856043473]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

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