BLACKSTONE ASCENT MULTIAXIAL SCREWS


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K073420
Device Name BLACKSTONE ASCENT MULTIAXIAL SCREWS
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 12/05/2007
Decision Date 02/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No