INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE


Device Classification Name

intervertebral fusion device with integrated fixation, cervical

510(k) Number K122008
Device Name INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
Applicant
INCITE INNOVATION LLC
1500 main street
ste. 2410
springfield, 
MA 
01115

Applicant Contact john kirwan
Correspondent
INCITE INNOVATION LLC
1500 main street
ste. 2410
springfield, 
MA 
01115

Correspodent Contact john kirwan
Regulation Number 888.3080
Classification Product Code
OVE  
Date Received 07/09/2012
Decision Date 11/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No