BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K080394
Device Name BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM
Applicant
BLACKSTONE MEDICAL, INC.
1211 hamburg turnpike
suite 300
wayne, 
NJ 
07470

Applicant Contact whitney g torning
Correspondent
BLACKSTONE MEDICAL, INC.
1211 hamburg turnpike
suite 300
wayne, 
NJ 
07470

Correspodent Contact whitney g torning
Regulation Number 888.3050
Classification Product Code
KWP  
Date Received 02/13/2008
Decision Date 03/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No