MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K023498
Device Name MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
Original Applicant
BLACKSTONE MEDICAL, INC.
90 brooksdale dr.
springfield, 
MA 
01104

Original Contact dean e ciporkin
Regulation Number 888.3050
Classification Product Code
KWP  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received 10/18/2002
Decision Date 11/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No