BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K030595
Device Name BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM
Applicant
BLACKSTONE MEDICAL, INC.
90 brooksdale dr.
springfield, 
MA 
01104

Applicant Contact dean e ciporkin
Correspondent
BLACKSTONE MEDICAL, INC.
90 brooksdale dr.
springfield, 
MA 
01104

Correspodent Contact dean e ciporkin
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 02/25/2003
Decision Date 04/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No