BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K081177
Device Name BLACKSTONE MEDICAL, INC., PILLAR SPACER 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 888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received 04/25/2008
Decision Date 07/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No