BLACKSTONE SPINAL FIXATION SYSTEM SPACER


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K022399
Device Name BLACKSTONE SPINAL FIXATION SYSTEM SPACER
Original Applicant
BLACKSTONE MEDICAL, INC.
90 brooksdale dr.
springfield, 
MA 
01104

Original Contact alan lombardo
Regulation Number 888.3060
Classification Product Code
KWQ  
Subsequent Product Codes
MNH   MNI  
Date Received 07/23/2002
Decision Date 08/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No