MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM


Device Classification Name

screw, fixation, bone

510(k) Number K021579
Device Name MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM
Original Applicant
MAGLY ORTHOPEDICS, LLC
15009 ne 195th st.
woodinville, 
WA 
98072

Original Contact dave stinson
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 05/14/2002
Decision Date 08/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No