POSTERIOR CABLE SCREW


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K022908
Device Name POSTERIOR CABLE SCREW
Original Applicant
PIONEER SURGICAL TECHNOLOGY
375 river park circle
marquette, 
MI 
49855 -0627

Original Contact jonathan gilbert
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
JDQ  
Date Received 09/03/2002
Decision Date 01/22/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No