STAYFUSE GT-IP


Device Classification Name

screw, fixation, bone

510(k) Number K022726
Device Name STAYFUSE GT-IP
Original Applicant
PIONEER SURGICAL TECHNOLOGY
375 river park circle
marquette, 
MI 
49855 -0627

Original Contact kathy moran
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 08/16/2002
Decision Date 09/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No