HOWMEDICA OSTEONICS SHOULDER SCREW


information about

Device Classification Name

screw, fixation, bone

510(k) Number K002654
Device Name HOWMEDICA OSTEONICS SHOULDER SCREW
Original Applicant
HOWMEDICA OSTEONICS CORP.
359 veterans blvd.
rutherford, 
NJ 
07070 -2584

Original Contact jennifer a daudelin
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 08/25/2000
Decision Date 09/22/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Special
Reviewed by Third Party No

Combination Product

No