SHUTTLE STOP


the company

Device Classification Name

cement obturator

510(k) Number K000587
Device Name SHUTTLE STOP
Original Applicant
ISOTIS NV
49 plain st.
north attleboro, 
MA 
02760

Original Contact cynthia j.m. nolte
Regulation Number 878.3300
Classification Product Code
LZN  
Date Received 02/22/2000
Decision Date 05/04/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No