Anterior Cervical Interbody Fusion Device 45-05-06P

GUDID 00840019908115

ACIF-Wide 5 degree 6mm

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device ID00840019908115
NIH Device Record Keyacc5345b-b7a6-4628-8085-57cf1540ecbc
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnterior Cervical Interbody Fusion Device
Version Model Number45-05-06P
Catalog Number45-05-06P
Company DUNS079398589
Company NamePRECISION 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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840019908115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019908115]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-04-12

On-Brand Devices [Anterior Cervical Interbody Fusion Device]

00840019922142ACIF Wide System (Empty)
00840019922135Implant caddy
00840019922128Outer case
00840019922111ACIF Wide System Assembly
00840019922104ACIF-Wide 12mm Sizer
00840019922098ACIF-Wide 11mm Sizer
00840019922074ACIF-Wide 9mm Sizer
00840019922067ACIF-Wide 8mm Sizer
00840019922050ACIF-Wide 7mm Sizer
00840019922029Sterilization Case Assembly
00840019922012Implant Caddy
00840019922005Sterilization Case
00840019921992Inserter Assembly
008400199219855° & 10° X 12mm Trial Assembly
008400199219785° & 10° X 11mm Trial Assembly
008400199219615° & 10° X 10mm Trial Assembly
008400199219475° & 10° X 8mm Trial Assembly
008400199219235° & 10° X 6mm Trial Assembly
00840019922081ACIF-Wide 10mm Sizer
00840019922043ACIF-Wide 6mm Sizer
00840019922036ACIF-Wide 5mm Sizer
008400199219545° & 10° X 9mm Trial Assembly
008400199219305° & 10° X 7mm Trial Assembly
008400199219165° & 10° X 5mm Trial Assembly
00840019907859ACIF Cage Peek 5 degree x 12mm
00840019907842ACIF Cage Peek 5 degree x 11mm
00840019907835ACIF Cage Peek 5 degree x 10mm
00840019907828ACIF Cage Peek 5 degree x 9mm
00840019907811ACIF Cage Peek 5 degree x 8mm
00840019907804ACIF Cage Peek 5 degree x 7mm
00840019907798ACIF Cage Peek 5 degree x 6mm
00840019907781ACIF Cage Peek 5 degree x 5mm
00840019908252ACIF-Wide 10 degree 12mm
00840019908245ACIF-Wide 10 degree 11mm
00840019908238ACIF-Wide 10 degree 10mm
00840019908221ACIF-Wide 10 degree 9mm
00840019908214ACIF-Wide 10 degree 8mm
00840019908207ACIF-Wide 10 degree 7mm
00840019908191ACIF-Wide 10 degree 6mm
00840019908184ACIF-Wide 10 degree 5mm
00840019908177ACIF-Wide 5 degree 12mm
00840019908160ACIF-Wide 5 degree 11mm
00840019908153ACIF-Wide 5 degree 10mm
00840019908146ACIF-Wide 5 degree 9mm
00840019908139ACIF-Wide 5 degree 8mm
00840019908122ACIF-Wide 5 degree 7mm
00840019908115ACIF-Wide 5 degree 6mm
00840019908108ACIF-Wide 5 degree 5mm
00840019907934ACIF Cage Peek 10 degree x 12 mm
00840019907927ACIF Cage Peek 10 degree x 11 mm

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