INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVI 22-9220

GUDID B038229220

ANCHORED CERVICAL INTERBODY, 5MM IMPLANT, 12x14MM, 5 DEGREE

INCITE INNOVATION

Polymeric spinal fusion cage, sterile
Primary Device IDB038229220
NIH Device Record Keydbb587ba-e509-4b02-a31a-988aa4eba12f
Commercial Distribution StatusIn Commercial Distribution
Brand NameINCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVI
Version Model Number22-9220
Catalog Number22-9220
Company DUNS005840144
Company NameINCITE INNOVATION
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB038229220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-22

On-Brand Devices [INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVI]

B038229225ANCHORED CERVICAL INTERBODY DEVICE, 10MM IMPLANT, 12x14MM, 5 DEGREE
B038229224ANCHORED CERVICAL INTERBODY DEVICE, 9MM IMPLANT, 12x14MM, 5 DEGREE
B038229222ANCHORED CERVICAL INTERBODY, 7MM IMPLANT, 12x14MM, 5 DEGREE
B038229221ANCHORED CERVICAL INTERBODY DEVICE, 6MM IMPLANT, 12x14MM, 5 DEGREE
B038229220ANCHORED CERVICAL INTERBODY, 5MM IMPLANT, 12x14MM, 5 DEGREE
B038229212LONG1ANCHORED CERVICAL INTERBODY DEVICE, ANCHOR, LONG
B038229211SHORT1ANCHORED CERVICAL INTERBODY DEVICE, ANCHOR, SHORT
B038227225ANCHORED CERVICAL INTERBODY DEVICE, 10MM IMPLANT, 14x16MM, 5 DEGREE
B038227224ANCHORED CERVICAL INTERBODY DEVICE, 9MM IMPLANT, 14x16MM, 5 DEGREE
B038227223ANCHORED CERVICAL INTERBODY DEVICE, 8MM IMPLANT, 14x16MM, 5 DEGREE
B038227222ANCHORED CERVICAL INTERBODY DEVICE, 7MM IMPLANT, 14x16MM, 5 DEGREE
B038227221ANCHORED CERVICAL INTERBODY DEVICE, 6MM IMPLANT, 14x16MM, 5 DEGREE
B038227220ANCHORED CERVICAL INTERBODY DEVICE, 5MM IMPLANT, 14x16MM, 5 DEGREE

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