BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K030581
Device Name BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
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 888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received 02/24/2003
Decision Date 06/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No