declaration of conformity

of 15

DECLARATION OF CONFORMITY

MANUFACTURER: NuVasive

®, Incorporated

7475 Lusk Blvd.

San Diego, CA 92121

United States of America

(858) 909-1800

EUROPEAN REPRESENTATIVE: NuVasive® UK Ltd.

Suite B,

Ground Floor

Caspian House

The Waterfront

Elstree, WD6 3BS

UK

+44 (0) 208 238 7850

PRODUCT: X-CORE - Vertebral Body Replacement System Implants

(See Attached List)

CLASSIFICATION: Class IIb, Rule 8 according to Annex IX of the MDD

CONFORMITY ASSESSMENT

ROUTE: Annex II, Section 3

We herewith declare that the abovementioned products meet the provisions of the Council Directive

93/42/EEC for medical devices. All supporting documentation is retained under the premises of the

manufacturer.

STANDARDS APPLIED: ISO 13485: 2003

NOTIFIED BODY: BSI Healthcare (ID #0086)

Kitemark Court,

Davy Avenue,

Knowlhill, Milton Keynes,

MK5 8PP, United Kingdom

YEAR OF CE MARKING: 2010

EC CERTIFICATE NUMBER CE 96026

ISSUED BY: NuVasive®, Incorporated

7475 Lusk Boulevard

San Diego, California 92121


PREPARED BY: 19 JANUARY 2017

Cynthia Adams Date

Specialist, Regulatory Affairs

of 15

MANUFACTURER’S DECLARATION OF CONFORMITY AUSTRALIAN THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002

This is a declaration of conformity made under clause 1.8 of Schedule 3 to the Therapeutic Goods (Medical

Devices) Regulations 2002.

FULL QUALITY ASSURANCE PROCEDURES

Manufacturer's Name: NuVasive®, Incorporated

Business Address: 7475 Lusk Blvd

San Diego, CA 92121


(858) 909-1800

Medical Device(s): See attached schedule

Classification: Class IIb - classification rule 3.4(2) of Schedule 2

GMDN Code and Term: 57806 Vertebral body prosthesis, non-sterile

Scope of Application: All

Each kind of medical device to which the system has been applied complies with the applicable provisions

of the essential principles, the classification rules, and the full quality assurance procedures, at each stage,

from the design of the device until its final inspection before being supplied.

Notified Body: BSI Healthcare (ID #0086)

Kitemark Court,

Davy Avenue,

Knowlhill, Milton Keynes,

MK5 8PP, United Kingdom

Full quality assurance ISO 13485 certificate: FM 93927

procedures certificate:

Design examination EC certificate number: CE 96026

certificate (if applicable):

Standards Applied: ISO 13485: 2003

Year of CE Marking: 2010

Authorised Signatory: 19 JANUARY 2017

Cynthia Adams Date

Specialist, Regulatory Affairs

of 15

ATTACHED LIST TO DECLARATION OF CONFORMITY FOR VBR SYSTEM

Material Material Description

1552191 X-CORE Set Screw, Core

1564933 X-CORE Mini Lock Screw

1568492 X-CORE 2 Ti Lock Screw, Ø16 Core

5161600 X-CORE 2 Ti Endcap, 16mm Rnd 0° Ø16


5163000 X-CORE 2 Ti Endcap, Ø16x16x30mm 0°


5163014 X-CORE 2 Ti Endcap, Ø16x16x30mm -4°












5185000 X-CORE 2 Ti Endcap, 18x50mm Ø16 0°

5950011 X-CORE Mini Lock Screw, Endcap

5950400 X-CORE Mini Endcap, Ø16 Par Round Ø14

5951520 X-CORE Mini Endcap, 15x12mm 0°

5951526 X-CORE Mini, 15x12mm 7° Top Lord Ø12

5951527 X-CORE Mini, 15x12mm 7° Btm Lord Ø12

5951740 X-CORE Mini Ti Endcap, 17x14mm 0°

5951746 X-CORE Mini, 17x14mm 7° Top Lord Ø12

5951747 X-CORE Mini, 17x14mm 7° Btm Lord Ø12

5952141 X-CORE Mini Core, Ø12mm 15-20mm














5960011 X-CORE Mini Lock Screw, Endcap

5960033 X-CORE Mini Lock Screw, Ø12mm

5960034 X-CORE Mini Lock Screw, Ø14mm

5960200 XC Mini Endcap, 14mm Parallel Round Ø12

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5960400 XC Mini Endcap, 16mm Parallel Round Ø14








5962520 XC Mini Endcap, 15x12mm Parallel Ø12

5962521 XC Mini Endcap, 15x12mm Contour Top Ø12

5962526 XC Mini Endcap, 15x12mm 7° Lord Btm Ø12

5962527 XC Mini Endcap, 15x12mm 7° Lord Top Ø12





5963740 XC Mini Endcap, 17x14mm Par Top Ang Ø14

5963745 XC Mini Endcap, 17x14mm Par Btm Ang Ø14

5963746 XCMini Endcap 17x14mm 4° Kyp Btm Ang Ø14

5963747 XCMini Endcap 17x14mm 4° Kyp Top Ang Ø14

5963960 XC Mini Endcap, 19x16mm Par Top Ang Ø14

5963965 XC Mini Endcap, 19x16mm Par Btm Ang Ø14

5963966 XCMini Endcap 19x16mm 4° Kyp Btm Ang Ø14

5963967 XCMini Endcap 19x16mm 4° Kyp Top Ang Ø14
















5960011P2 X-CORE Mini Lock Screw, Endcap

5960200P2 XC Mini Endcap, 14mm Parallel Round Ø12

5960400P2 XC Mini Endcap, 16mm Parallel Round Ø14

5962152P2 X-CORE Mini Core, Ø12mm 15-20mm







5962520P2 XC Mini Endcap, 15x12mm Parallel Ø12

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5962521P2 XC Mini Endcap, 15x12mm Contour Top Ø12

5962526P2 XC Mini Endcap, 15x12mm 7° Lord Btm Ø12

5962527P2 XC Mini Endcap, 15x12mm 7° Lord Top Ø12





5963740P2 XC Mini Endcap, 17x14mm Par Top Ang Ø14

5963745P2 XC Mini Endcap, 17x14mm Par Btm Ang Ø14

5963746P2 XCMini Endcap 17x14mm 4° Kyp Btm Ang Ø14

5963747P2 XCMini Endcap 17x14mm 4° Kyp Top Ang Ø14

5963960P2 XC Mini Endcap, 19x16mm Par Top Ang Ø14

5963965P2 XC Mini Endcap, 19x16mm Par Btm Ang Ø14

5963966P2 XCMini Endcap 19x16mm 4° Kyp Btm Ang Ø14

5963967P2 XCMini Endcap 19x16mm 4° Kyp Top Ang Ø14



















6182200 X-Core 2 Endcap, Ø22mm-Ø18 0° Round

















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6531300 X-CORE Endcap, 30mm 0° Symmetric Ø18




6531308 X-CORE Endcap, 30mm -4° Symmetric Ø18






















6533131 X-CORE Endcap, 30mm 0° Ø18mm

6533140 X-CORE Endcap, 40mm -4° Symmetic Ø18


6533150 X-CORE Endcap, 50mm -4° Symmetic Ø18


6533230 X-CORE Endcap, 30mm 0° Symmetic Ø18

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6533431 X-CORE Endcap, 30mm -4° Ø18mm





























6537122 X-CORE Endcap, 22mm 0° Round Ø18









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6539001 X-CORE Lock Screw, 18mm Endcap

6539002 X-CORE Lock Screw, 22mm Endcap

6541300 X-CORE Endcap, 30mm 0° Asymmetric Ø18




6541308 X-CORE Endcap, 30mm -4° Asymmetric Ø18





































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6581220 X-CORE Endcap, 22mm 0° Round Ant Ø18




















6590010 X-CORE Extender, Ø18mm

6590011 X-CORE Extender, Ø22mm

6590121 X-CORE Core, Ø18mm Small

6590122 X-CORE Core, Ø18mm Med

6590123 X-CORE Core, Ø18mm Large

6590131 X-CORE Core, Ø22mm Small

6590132 X-CORE Core, Ø22mm Med

6590133 X-CORE Core, Ø22mm Large

6591011 X-CORE Core, Ø18mm 20-22mm














7110001 X-CORE 2 Ti Lock Screw, Ø16 Core

7110003 X-CORE 2 Ti Lock Screw, Core

7160012 X-CORE 2 Ti Core, Ø16x12mm Static


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7160022 X-CORE 2 Ti Core, Ø16x16-22mm








7162000 X-CORE 2 Ti Lock Screw, Endcap





































7262600 XCORE 2 Ti Endcap, 26mm Rnd 0° Ø22





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5163000006 XCORE 2 Ti Endcap, Ø16x16x30mm 0°


5163014006 XCORE 2 Ti Endcap, Ø16x16x30mm -4°






















7110001006 X-CORE 2 Ti Core Lock Screw, Ø16 Core

7110003006 X-CORE 2 Ti Lock Screw, Ø18 Ø22 Core

7160025006 X-CORE 2 Ti Core,Ø16x18-25mm


7160049006 X-CORE 2 Ti Core,Ø16x30-49mm



7162000006 XCORE 2 Ti Lock Screw, Endcap






7180025A X-CORE 2 Ti Core, Ø18x20-25mm Autolock








of 15











5161600P2 X-CORE 2 Ti Endcap, 16mm Rnd 0° Ø16


5163000P2 X-CORE 2 Ti Endcap, Ø16x16x30mm 0°


5163014P2 X-CORE 2 Ti Endcap, Ø16x16x30mm -4°









5960011P2 X-CORE Mini Ti Lock Screw, Endcap

5960200P2 X-CORE Mini Endcap, Ø14 Par Round Ø12

5960400P2 X-CORE Mini Endcap, Ø16 Par Round Ø14

5962152P2 X-CORE Mini, 15-20mm Ø12mm







5962520P2 X-CORE Mini Ti, 15x12mm Ø12 Parallel

5962521P2 X-CORE Mini Ti, 15x12mm Ø12 Convex Top

5962526P2 X-CORE Mini Ti,15x12mm Ø12 7° Lord Btm

5962527P2 X-CORE Mini Ti, 15x12mm Ø12 7° Lord Top



5962746P2 X-CORE Mini Ti, 17x14mm Ø12 7° Lord Btm


5963740P2 X-CORE Mini Ti, 17x14mm Ø14 Par Ang Top

5963745P2 X-CORE Mini Ti, 17x14mm Ø14 Par Ang Btm

5963746P2 X-CORE Mini Ti, 17x14mm Ø14 4° Ang Btm

5963747P2 X-CORE Mini Ti, 17x14mm Ø14 4° Ang Top

5963960P2 X-CORE Mini Ti, 19x16mm Ø14 Par Ang Top

5963965P2 X-CORE Mini Ti, 19x16mm Ø14 Par Ang Btm

5963966P2 X-CORE Mini Ti, 19x16mm Ø14 4° Ang Btm

5963967P2 X-CORE Mini Ti, 19x16mm Ø14 4° Ang Top


of 15






























6186000P2 X-CORE 2 Ti Endcap, Ø18 18x60 0° Para

6186004P2 X-CORE 2 Ti Endcap, Ø18 18x60 4° Lord

6186008P2 X-CORE 2 Ti Endcap, Ø18 18x60 8° Lord

6186014P2 X-CORE 2 Ti Endcap, Ø18 18x60 4° Kyph


















of 15






7160012P2 X-CORE 2 Ti Core, Ø16x12mm Static


7160022P2 X-CORE 2 Ti Core, Ø16x16-22mm








7162000P2 X-CORE 2 Ti Lock Screw, Endcap



7180025AP2 X-CORE 2 Ti Core, Ø18x20-25mm Autolock
































of 15


















7262600P2 XCORE 2 Ti Endcap, 26mm Rnd 0° Ø22






declaration of conformity

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