BLACKSTONE SFS PARALLEL ROD CONNECTORS


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K080407
Device Name BLACKSTONE SFS PARALLEL ROD CONNECTORS
Applicant
BLACKSTONE MEDICAL, INC.
1211 hamburg turnpike
suite 300
wayne, 
NJ 
07470

Applicant Contact whitney g torning
Correspondent
BLACKSTONE MEDICAL, INC.
1211 hamburg turnpike
suite 300
wayne, 
NJ 
07470

Correspodent Contact whitney g torning
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received 02/14/2008
Decision Date 03/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls