MULTI-AXIAL CROSS (MAC) CONNECTOR


definition

Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K000965
Device Name MULTI-AXIAL CROSS (MAC) CONNECTOR
Original Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Original Contact terry sheridan powell
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received 03/27/2000
Decision Date 05/11/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Special
Reviewed by Third Party No

Combination Product

No