BLACKSTONE POSTERIOR CERVICAL SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K030197
Device Name BLACKSTONE POSTERIOR CERVICAL 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 Code
MNI  
Date Received 01/21/2003
Decision Date 06/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls