ORTHOFIX M6-C Artificial Cervical Disc Instructions
- June 6, 2024
- ORTHOFIX
Table of Contents
INSTRUCTIONS FOR USE
Important Information – Please Read Prior to Use
These supplementary Instructions for Use pertain to European Medical Device Regulations 2017/745 (MDR) Class I devices are associated with the Orthofix medical device systems listed below. For full prescribing information please reference the device system Instructions for Use:
- M6-em Artificial Cervical Disc
- M6-C® Manual Surgical Instruments
- M6-Um Artificial Cervical Disc
- M6-L® Manual Surgical Instruments
Labeling pertaining to Serious Incidents
Any serious incident that has occurred in relation to the devices subject
of the supplementary Instructions for Use should be reported to Spinal
Kinetics LLC, 501 Mercury Drive Sunnyvale, CA 94085, USA, by telephone at
1-408-636-2500 or by e-mail at
www.orthofix.com or
[email protected] and the competent authority
of the Member State in which the user and/or patient is established.
NEW MDR SYMBOLS USED ON LABELING FOR CLASS I DEVICES
| Medical device
---|---
| Quantity or packaging unit
Orthofix US LLC
3451 Plano Parkway
Lewisville, Texas 75056-9453 U.S.A.
+1 214 -937-3199/+1 8 8 8 -298 -570 0
www.orthofix.com
Spinal Kinetics LLC
501 Mercury Drive
Sunnyvale, CA 94085 USA
+1 408-636-2500
www.orthofix.com
[email protected]
** PS Medical Product Service GmbH
Borngasse 20
35619 Braunfels
Germany
+49 6442 962073**