UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K021623
Device Name UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS
Original Applicant
IAME, INC.
200 gregory lane, suite c-100
pleasant hill, 
CA 
94523 -3389

Original Contact david w schlerf
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received 05/16/2002
Decision Date 09/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No