Textová podoba smlouvy Smlouva č. 2141778: Kupní smlouva SZM - fůze kosti pánevní

                        SI-BONE Inc.
SL-BONE 300060 Rev B

Declaration of Conformity

Manufacturer:

SI-BONÉ Ino.
3055 Olin Ave. Suite 2200
San Jose, Ca. 95128
USA

European Authorized Representative:

MedPass International Limited
Windsor House, Barnett Way
Barnwood

Gloucester GL4 3RT, United Kingdom

Products:
Classification per MDD 93/42/EEC: Class lia / IIb, Annex IX

We hereby declare that the distributed CE marked products, specified above, conform to the product(s)
covered by the "CE Marking of Conformity Certificate", reference number:3804024CE01, first issued on
11/11/2010, ISO 13485:2003 | certificate 4£ 3804024 first issued on 9/1/2010 and delivered by DEKRA
Certification B.V., Arnhem, The Netherlands, Notified Body Identification Number 0344, in accordance with
Annex II of the "EC-Directive", the Council Directive 93/42/EEC of 14 June 1993, concerning medical

devices.

In addition, we ensure and declare that the distributed CE marked products, as mentioned and falling within

Class Ila A IIb, meet the provisions of the EC-Directive which apply to them.

This declaration is based on the application of the Ouality System approved for the design, manufacture
and final inspection of the products concerned, in accordance with Annex li of the EC-Directive. The
conformity of the full guality assurance system set out in Annex II, is described in the said CE Marking of
Conformity Certificate, issued and delivered by DEKRA Certification B.V.

This Declaration of Conformity covers the iFuse Sacroiliac Joint Implant, Steinmann Pins, and Cannulated
Drilis as specified in the product list belonging to this declaration, and is valid for all products concerned

bearing the CE marking and manufactured at the following site(s): San Jose, California USA

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SI-BONE Inc.
300060 Rev B

Declaration of Conformity

 

 

 

  

 
    
 
 

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SI-BONE Fusion Rod 7.0 x 30mn;1 10006 N/A
7035 SI-BONE Fusion Rod 7.0 x 35mm 10007 N/A
7040 SI-BONE Fusion Rod 7.0 x 40mm 10008 N/A
7045 SI-BONE Fusion Rod 7.0 x 45mm 10012 N/A
7050 SI-BONE Fusion Rod 7.0 x 50mm 10013 N/A
7055 SI-BONE Fusion Rod 7.0 x 55mm 11868704110 N/A
7060 SI-BONE Fusion Rod 7.0 x 60mm 7914003181009 N/A
7065 SI-BONE Fusion Rod 7.0 x 65mm 7914003181010 N/A
7070 SI|-BONE Fusion Rod 7.0 x 70mm 7753003181011 N/A
4030 SI-BONE Fusion Rod 4.0 x 30mm 10014 N/A
4035 SI-BONE Fusion Rod 4.0 x 35mm 10015 N/A
4040 SI-BONE Fusion Rod 4.0 x 40mm 10016 N/A
4045 SI-BONE Fusion Rod 4.0 x 45mm 10017 N/A
4050 SI-BONE Fusion Rod 4.0 x 50mm 7987003323007 N/A
4055 SI-BONE Fusion Rod 4.0 x 55mm 7987003323008 N/A
4060 SI-BONE Fusion Rod 4.0 x 60mm 7982003323009 N/A
4065 S|I-BONE Fusion Rod 4.0 x 65mm 7987003323010 N/A
4070 SI-BONE Fusion Rod 4.0 x 70mm 7987003323011 N/A
500078 Steinmann Pin, 3.2mm R2401 N/A
500079 Steinmann Pin, 2.0mm RCS08 N/A
500095 Blunt Steinmann Pin, 3.2 R8906 N/A
500096 Blunt Steinmann Pin, 2.0 S9K0D N/A
500090 Push Pin, 3.2 | SDBOB N/A
500091 Push Pin, 2.0 RCS09 N/A
500082 Cannulated Drill, 4.0mm x 2.0mm N75297 N/ZA
500076 Cannulated Drill, 7.0mm x 3.2mm 85638 N/A

 

 

 

 

 

 

Place of Issuance: San Jose, Ca.

Signature 8: Date of
Issuance % //. /ý.„ Zo/2-
7

Director of GAuality / Management Representative Date

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