ACCIN PEDICLE SCREW SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K073531
Device Name ACCIN PEDICLE SCREW SYSTEM
Applicant
ACCELERATED INNOVATION, LLC
1033 us highway 46 east
suite a204
clifton, 
NJ 
07013

Applicant Contact michael kvitnitsky
Correspondent
ACCELERATED INNOVATION, LLC
1033 us highway 46 east
suite a204
clifton, 
NJ 
07013

Correspodent Contact michael kvitnitsky
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWQ   MNI  
Date Received 12/17/2007
Decision Date 02/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No