TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K010776
Device Name TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS
Original Applicant
CORIN U.S.A.
10500 university center dr.,
suite 190
tampa, 
FL 
33612

Original Contact joel batts
Regulation Number 888.3070
Classification Product Code
MNH  
Date Received 03/14/2001
Decision Date 04/06/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Special
Reviewed by Third Party No

Combination Product

No