INCITE INNOVATION ANCHORED CERVICAL INERBODY DEVIC 22-9223

GUDID B038229223

ANCHORED CERVICAL INTERBODY DEVICE, 8MM IMPLANT, 12x14MM, 5 DEGREE

INCITE INNOVATION

Polymeric spinal fusion cage, sterile
Primary Device IDB038229223
NIH Device Record Key6f041575-737d-48fc-aac7-6a4b231072e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameINCITE INNOVATION ANCHORED CERVICAL INERBODY DEVIC
Version Model Number22-9223
Catalog Number22-9223
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
HIBCCB038229223 [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

Devices Manufactured by INCITE INNOVATION

B0382272201 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE2020-04-08 ANCHORED CERVICAL INTERBODY DEVICE, 5MM IMPLANT, 14x16MM, 5 DEGREE
B0382272211 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE2020-04-08 ANCHORED CERVICAL INTERBODY DEVICE, 6MM IMPLANT, 14x16MM, 5 DEGREE
B0382272221 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE2020-04-08 ANCHORED CERVICAL INTERBODY DEVICE, 7MM IMPLANT, 14x16MM, 5 DEGREE
B0382272231 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE2020-04-08 ANCHORED CERVICAL INTERBODY DEVICE, 8MM IMPLANT, 14x16MM, 5 DEGREE
B0382272241 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE2020-04-08 ANCHORED CERVICAL INTERBODY DEVICE, 9MM IMPLANT, 14x16MM, 5 DEGREE
B0382272251 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE2020-04-08 ANCHORED CERVICAL INTERBODY DEVICE, 10MM IMPLANT, 14x16MM, 5 DEGREE
B0382292201 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE2020-04-08 ANCHORED CERVICAL INTERBODY, 5MM IMPLANT, 12x14MM, 5 DEGREE
B0382292211 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE2020-04-08 ANCHORED CERVICAL INTERBODY DEVICE, 6MM IMPLANT, 12x14MM, 5 DEGREE

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