DISCOVERY TiNano ACIF 105010505

GUDID B521105010505

DISCOVERY TiNano ACIF 14mm X 16mm X 5 X 5mm

AURORA SPINE, INC.

Polymeric spinal fusion cage, sterile Polymeric spinal fusion cage, sterile
Primary Device IDB521105010505
NIH Device Record Keyc57be7bd-c1df-4239-96f4-b5a9645ff17f
Commercial Distribution Discontinuation2019-02-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDISCOVERY TiNano ACIF
Version Model Number105010505
Catalog Number105010505
Company DUNS079119091
Company NameAURORA SPINE, INC.
Device Count1
DM Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx

Device Dimensions

Height5 Millimeter
Angle5 degree
Width16 Millimeter
Length14 Millimeter
Height5 Millimeter
Angle5 degree
Width16 Millimeter
Length14 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB521105010505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-04
Device Publish Date2017-02-02

On-Brand Devices [DISCOVERY TiNano ACIF]

B521105010509DISCOVERY TiNano ACIF 14mm X 16mm X 5 9mm
B521105010508DISCOVERY TiNano ACIF 14mm X 16mm X 5 X 8mm
B521105010507DISCOVERY TiNano ACIF 14mm X 16mm X 5 X 7
B521105010505DISCOVERY TiNano ACIF 14mm X 16mm X 5 X 5mm

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