ShurFit ACIF Systems 45-CP-1008

GUDID 00840019908054

10° X 8mm Implant

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device ID00840019908054
NIH Device Record Key7999bca9-cfc5-4a75-b61a-836f294cebdc
Commercial Distribution StatusIn Commercial Distribution
Brand NameShurFit ACIF Systems
Version Model Number45-CP-1008
Catalog Number45-CP-1008
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
GS100840019908054 [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

[00840019908054]

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 [ShurFit ACIF Systems]

0084001990809210° X 12mm Implant
0084001990808510° X 11mm Implant
0084001990807810° X 10mm Implant
0084001990806110° X 9mm Implant
0084001990805410° X 8mm Implant
0084001990804710° X 7mm Implant
0084001990803010° X 6mm Implant
0084001990802310° X 5mm Implant
008400199080165° X 12mm Implant
008400199080095° X 11mm Implant
008400199079965° X 10mm Implant
008400199079895° X 9mm Implant
008400199079725° X 8mm Implant
008400199079655° X 7mm Implant
008400199079585° X 6mm Implant
008400199079415° X 5mm Implant
00840019936750Implant Kit

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