HALM ZIELKE INSTRUMENTATION SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K024125
Device Name HALM ZIELKE INSTRUMENTATION SYSTEM
Original Applicant
MICOMED ORTHO GMBH
13195 seagrove st.
san diego, 
CA 
92130

Original Contact corrine m bonfiglio
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 12/16/2002
Decision Date 09/22/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No