BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K022605
Device Name BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER
Original Applicant
BLACKSTONE MEDICAL, INC.
90 brookdale dr.
springfield, 
MA 
01104

Original Contact alan lombardo
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 08/06/2002
Decision Date 08/21/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No