INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE 22-9222

GUDID B0382292221

ANCHORED CERVICAL INTERBODY, 7MM IMPLANT, 12x14MM, 5 DEGREE

INCITE INNOVATION

Polymeric spinal interbody fusion cage
Primary Device IDB0382292221
NIH Device Record Key63da0c06-43d7-4c97-a1b9-71987c6965b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameINCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE
Version Model Number22-9222
Catalog Number22-9222
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
HIBCCB0382292221 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-08
Device Publish Date2020-03-31

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

B0382292251ANCHORED CERVICAL INTERBODY DEVICE, 10MM IMPLANT, 12x14MM, 5 DEGREE
B0382292241ANCHORED CERVICAL INTERBODY DEVICE, 9MM IMPLANT, 12x14MM, 5 DEGREE
B0382292221ANCHORED CERVICAL INTERBODY, 7MM IMPLANT, 12x14MM, 5 DEGREE
B0382292211ANCHORED CERVICAL INTERBODY DEVICE, 6MM IMPLANT, 12x14MM, 5 DEGREE
B0382292201ANCHORED CERVICAL INTERBODY, 5MM IMPLANT, 12x14MM, 5 DEGREE
B0382272251ANCHORED CERVICAL INTERBODY DEVICE, 10MM IMPLANT, 14x16MM, 5 DEGREE
B0382272241ANCHORED CERVICAL INTERBODY DEVICE, 9MM IMPLANT, 14x16MM, 5 DEGREE
B0382272231ANCHORED CERVICAL INTERBODY DEVICE, 8MM IMPLANT, 14x16MM, 5 DEGREE
B0382272221ANCHORED CERVICAL INTERBODY DEVICE, 7MM IMPLANT, 14x16MM, 5 DEGREE
B0382272211ANCHORED CERVICAL INTERBODY DEVICE, 6MM IMPLANT, 14x16MM, 5 DEGREE
B0382272201ANCHORED CERVICAL INTERBODY DEVICE, 5MM IMPLANT, 14x16MM, 5 DEGREE

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